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ETHICON ENDO-SURGERY, INC.

United States·US-MF-000013107

Last updated September 17, 2026

Information

Country: United States
Address: 475, Calle C , Guaynabo, PUERTO RICO , United States
Website: its.jnj.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Marjorie Medina
EUDAMED SRN: US-MF-000013107
FDA FEI Number: 1527736
DUNS Number: —

Catalogue (313)

Page 5 of 7

Device	Model / Reference	Registries	Class	Status
Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter	K961390	FDA 510(k)	Class II	Active
Modified Endopath Ils	K940967	FDA 510(k)	Class II	Active
Endopath* Tristar Flat Bladed Surgical Obturator & Sleeve	K952842	FDA 510(k)	Class II	Active
Protectiv Acuvance Iv Catheter System	K012128	FDA 510(k)	Class II	Active
Shielded Surgical Trocar	K971475	FDA 510(k)	Class II	Active
11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic, 14 Gauge Probe, Ultrasound, Housing Stereotactic, Housing, Ult	K992813	FDA 510(k)	Class II	Active
Autobahn Tissue Closure Device And Disposable Cartridge	K042897	FDA 510(k)	Class II	Active
Endopath Non-Bladed Solid Obturator Trocar System	K011538	FDA 510(k)	Class II	Active
Ultracision Harmonic Scalpel Blades, Model Dh105, Dh145, Sh105, Sh145, Hc145	K010898	FDA 510(k)	U	Active
Acuvance Plus Safety Iv Catheter, Protectiv Plus Safety Iv Catheter, Optiva Iv Catheter	K030571	FDA 510(k)	Class II	Active
Hand-Held Retractor, Dissector & Dissector	K955120	FDA 510(k)	Class II	Active
Proximate Hcs Hemorrhoidal Circular Stapler And Accessories	K991030	FDA 510(k)	Class II	Active
Mammotome Mr Biopsy System	K042753	FDA 510(k)	Class II	Active
Endopath(r) Tristar(tm) Dissector And Tissue Manipulator	K946241	FDA 510(k)	Class II	Active
Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter	K110385	FDA 510(k)	Class II	Active
Ethicon Endo Surgery Endoscopic Suturing System	K061770	FDA 510(k)	Class II	Active
Endopath Optiview Optical Surgical Obturator And Sleeve	K972578	FDA 510(k)	Class II	Active
Endopath And Proximate Linear Cutters	K980023	FDA 510(k)	Class II	Active
ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)	K223760	FDA 510(k)	Class II	Active
Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps	K091259	FDA 510(k)	Class II	Active
Endoanchor And Openanchor	K013749	FDA 510(k)	Class II	Active
Harmonic Scalpel Blades And Shears	K060245	FDA 510(k)	U	Active
Micromark Ii Tissue Marker, Model C1535	K013413	FDA 510(k)	Class II	Active
Endopath Ultra Veress Needle	K983925	FDA 510(k)	Class II	Active
Ethicon Endo Surgery Sheath And Articulating Accessory Channel - Gastroscope, Model In0431; Colonoscope, Model In0432	K073484	FDA 510(k)	Class II	Active
Harmonic Ace Curved Shears With Hand Control, Model Ace23p, Ace36p	K042777	FDA 510(k)	U	Active
Endopath Endoscopic Tissue Retractor	K924916	FDA 510(k)	Class II	Active
8 Gauge Micromark Ii Tissue Marker, Models C1540 & C1535	K020276	FDA 510(k)	Class II	Active
Endopath Disposable Flexible Surgical Cannula	K931111	FDA 510(k)	Class II	Active
Indigo Optima Laser System	K013493	FDA 510(k)	Class II	Active
Proximate Pph Hemorrhoidal Circular Stapler And Accessories	K051301	FDA 510(k)	Class II	Active
Contour Curved Cutter Stapler And Reloads, Models: Cs40b, Cs40g, Cr40b, Cr40g	K091322	FDA 510(k)	Class II	Active
Endopath Endoscopic Tissue Fastening System (etfs)	K972679	FDA 510(k)	Class II	Active
Indigo Laseroptic Treatment System	K003952	FDA 510(k)	Class II	Active
Instrument, Ultrasonic, Scalpel	K990362	FDA 510(k)	Class II	Active
Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System	K030472	FDA 510(k)	Class II	Active
Ethicon Endo-Surgery 5mm Laparoscopic Multi-Feed Stapler	K102632	FDA 510(k)	Class II	Active
Ultracision 5mm Instruments	K983316	FDA 510(k)	U	Active
Endopath Sureseal Reducer Cap	K001220	FDA 510(k)	Class II	Active
Endopath Endoscopic Reloadable Linear Cutter With Safety Loc-Out And Reloading Unit	K945202	FDA 510(k)	Class II	Active
Ethicon Endo Surgery Articulating Needle Knife, Model 2504	K073046	FDA 510(k)	Class II	Active
Mammotome Hh Hand-Held Probe, Vacuum Set, Control Module, Hh Hand-Held Holster And Cables, Software Package, Footswitch,	K991980	FDA 510(k)	Class II	Active
Procedure Kits	K933160	FDA 510(k)	Class II	Active
Endopath Endoscopic Instruments	K984240	FDA 510(k)	Class II	Active
Inscope Multi-Clip Applier, Models In22321, In23321	K051950	FDA 510(k)	Class II	Active
Ligaclip 5 M/L Mm Endoscopic Multiple Clip Applier	K050344	FDA 510(k)	Class II	Active
Harmonic Scalpel Blades And Shears	K053056	FDA 510(k)	U	Active
Ultracision Harmonic Scalpel Coagulating Shears, Model Lcsc5, Lcsc1, Cs23c, Cs231, Cs14c, Cs141, Lcsb5, Lcsk5, Lcs15, Lcs16, Cs150	K002981	FDA 510(k)	Class II	Active
Proximate Curved And Straight Intraluminal Staplers	K983536	FDA 510(k)	Class II	Active
Percutaneous Surgical Set With 5mm Or 10mm Attachments	DEN110016	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 11, 2025	Z-0147-2026	—	open, classified	The devices were shipped unsterilized.
Apr 22, 2025	Z-1746-2025	—	open, classified	Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Mar 7, 2025	Z-1516-2025	—	open, classified	Identified curing issues with the silicone during the needles manufacturing process.
Mar 7, 2025	Z-1515-2025	—	open, classified	Identified curing issues with the silicone during the needles manufacturing process.
Mar 7, 2025	Z-1513-2025	—	open, classified	Identified curing issues with the silicone during the needles manufacturing process.
Mar 7, 2025	Z-1514-2025	—	open, classified	Identified curing issues with the silicone during the needles manufacturing process.
Dec 11, 2023	Z-0834-2024	—	open, classified	There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Jul 20, 2021	Z-2355-2021	—	open, classified	An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Jul 20, 2021	Z-2356-2021	—	open, classified	An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Jun 3, 2021	Z-2326-2021	—	terminated	Mislabeled: Labeled on the package as 60mm contains 45mm devices
Nov 7, 2019	Z-0656-2020	—	terminated	A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
Oct 3, 2019	Z-0202-2020	—	terminated	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Oct 3, 2019	Z-0201-2020	—	terminated	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Oct 3, 2019	Z-0200-2020	—	terminated	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Oct 3, 2019	Z-0203-2020	—	terminated	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
May 15, 2019	Z-1890-2019	—	terminated	Observed reported incidence rate for harm associated with intraoperative bleeding
May 15, 2019	Z-1888-2019	—	terminated	Observed reported incidence rate for harm associated with intraoperative bleeding
May 15, 2019	Z-1889-2019	—	terminated	Observed reported incidence rate for harm associated with intraoperative bleeding
Apr 11, 2019	Z-1273-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1270-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1277-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1268-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1276-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1267-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1271-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1272-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1269-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1278-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1274-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019	Z-1275-2019	—	completed	The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Dec 7, 2018	Z-0696-2019	—	terminated	Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Dec 7, 2018	Z-0695-2019	—	terminated	Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
May 3, 2018	Z-2049-2018	—	terminated	The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
May 3, 2018	Z-2048-2018	—	terminated	The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Mar 26, 2018	Z-1885-2018	—	terminated	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Mar 26, 2018	Z-1887-2018	—	terminated	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Mar 26, 2018	Z-1889-2018	—	terminated	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Mar 26, 2018	Z-1888-2018	—	terminated	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Mar 26, 2018	Z-1886-2018	—	terminated	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Oct 23, 2017	Z-0672-2018	—	terminated	There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
Mar 31, 2017	Z-2174-2017	—	terminated	There is a risk that the pinion gear in the device could fail under extreme use cases.
Jul 15, 2016	Z-0295-2017	—	terminated	Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Jul 15, 2016	Z-0296-2017	—	terminated	Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Sep 23, 2015	Z-0278-2016	—	terminated	Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
May 13, 2015	Z-2374-2015	—	terminated	Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
Feb 26, 2015	Z-1641-2015	—	terminated	During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
Aug 12, 2014	Z-2610-2014	—	terminated	The device may have a non-conforming component that may cause the device to fire an unformed staple.
Sep 30, 2013	Z-0150-2014	—	terminated	During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Sep 30, 2013	Z-0149-2014	—	terminated	During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Sep 30, 2013	Z-0151-2014	—	terminated	During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
May 13, 2013	Z-1530-2013	—	terminated	Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Apr 12, 2013	Z-1775-2013	—	terminated	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Apr 12, 2013	Z-1776-2013	—	terminated	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Apr 12, 2013	Z-1777-2013	—	terminated	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Apr 8, 2013	Z-1772-2013	—	terminated	The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
Nov 6, 2012	Z-0758-2013	—	terminated	Potential for self activation while the device is in use, which may result in unintended thermal damage.
Oct 4, 2012	Z-0918-2013	—	terminated	Damage to the packaging may have compromised the sterility of the device.
Aug 3, 2012	Z-0057-2013	—	terminated	Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
Mar 16, 2012	Z-1673-2012	—	terminated	Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when
Mar 2, 2012	Z-1627-2012	—	terminated	There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.
Jan 26, 2012	Z-1247-2012	—	terminated	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Jan 26, 2012	Z-1244-2012	—	terminated	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Jan 26, 2012	Z-1246-2012	—	terminated	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Jan 26, 2012	Z-1245-2012	—	terminated	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Jul 29, 2011	Z-3187-2011	—	terminated	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.
Sep 27, 2010	Z-0290-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0294-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0289-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0298-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0299-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0293-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0303-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0297-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0336-2011	—	terminated	This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. Pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.
Sep 27, 2010	Z-0295-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0301-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0300-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0291-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0302-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0292-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0304-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Sep 27, 2010	Z-0296-2011	—	terminated	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Jul 9, 2010	Z-2635-2010	—	terminated	The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.
Mar 27, 2009	Z-1068-2011	—	terminated	The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.
Mar 27, 2009	Z-1069-2011	—	terminated	The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.
Jan 13, 2009	Z-0361-2011	—	terminated	The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time, tissue manipulation, and a change in t
Dec 9, 2008	Z-0659-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0658-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0663-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0655-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0660-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0657-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0656-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0661-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Dec 9, 2008	Z-0662-2009	—	terminated	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Apr 24, 2008	Z-2162-2008	—	terminated	The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Apr 24, 2008	Z-2163-2008	—	terminated	The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Apr 24, 2008	Z-2161-2008	—	terminated	The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Apr 24, 2008	Z-2164-2008	—	terminated	The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Nov 6, 2007	Z-0565-2008	—	terminated	Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.