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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 4 of 7

Device	Model / Reference	Registries	Class	Status
Echelon Flex	PSEE45A	FDA UDI	Class II	Active
ECHELON Flex ENDOPATH	PCE45A	FDA UDI	Class II	Active
Endopath	TSB35	FDA UDI	Class II	Unknown
Echelon Flex	PCEE45A	FDA UDI	Class II	Active
Endopath	CTS45	FDA UDI	Class II	Unknown
Ligaclip	LT100	FDA UDI	Class II	Active
Ligaclip	LC307	FDA UDI	Class I	Active
Endopath	TSW35	FDA UDI	Class II	Unknown
Sedasys	SEDARM01	FDA UDI	Class III	Unknown
Ligaclip	LT400	FDA UDI	Class II	Active
Echelon	ECH45L	FDA UDI	Class II	Active
Ligaclip	LX307	FDA UDI	Class I	Active
Endopath	EPS05	FDA UDI	Class II	Active
DUALTO Energy System	ETHEM	FDA UDI	Class II	Active
Proximate	TX30G	FDA UDI	Class II	Active
Harmonic Ace	ACE45E	FDA UDI	U	Active
Ligaclip	LT202	FDA UDI	Class II	Active
Proximate	TRH60	FDA UDI	Class II	Active
ValuTrus	ADC255R	FDA UDI	Class II	Unknown
Sedasys	SEDBMU01	FDA UDI	Class III	Unknown
Echleon	ECH60R	FDA UDI	Class II	Active
Endopath	TR35B	FDA UDI	Class II	Unknown
Echelon Endopath	GST45B	FDA UDI	Class II	Active
Proximate	TLH60	FDA UDI	Class II	Active
ValuTrus	ADPH	FDA UDI	Class II	Unknown
Echelon	ECH60L	FDA UDI	Class II	Active
Endopath	EPH03	FDA UDI	Class II	Unknown
Harmonic Focus	FCS9	FDA UDI	U	Active
Endopath	6CB45	FDA UDI	Class II	Unknown
Echelon Flex	PLEE45A	FDA UDI	Class II	Active
ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)	K260196	FDA 510(k)	Class II	Active
Echelon Endopath	SC45	FDA UDI	Class II	Active
Harmonic Ace	ACE23E	FDA UDI	U	Active
Endopath	355HR	FDA UDI	Class II	Unknown
Ligaclip	EL214	FDA UDI	Class I	Active
Endopath	LONG45A	FDA UDI	Class II	Unknown
Echelon Flex	PLEE60A	FDA UDI	Class II	Active
Harmonic Ace	ACE36E	FDA UDI	U	Active
Endopath Xcel	B11LPH	FDA UDI	Class II	Active
Harmonic	HST01	FDA UDI	Class I	Unknown
Endopath	ATG45	FDA UDI	Class II	Unknown
Proximate	TRH30	FDA UDI	Class II	Active
Endopath	NAW45	FDA UDI	Class II	Active
Endopath	EPS03	FDA UDI	Class II	Active
Sedasys	SEDE3AMI	FDA UDI	Class III	Unknown
Cdh29a	CDH29A	EUDAMEDFDA UDI	Class IIb	Active
Proximate Articulating Linear Stapler	K932434	FDA 510(k)	Class II	Active
Harmonic Wave Coagulating Shears With Scissor Handel And Hand Control, Model Wave18s; Harmonic Disposable Torque Wrench	K062000	FDA 510(k)	U	Active
Endopath Ez45 Endoscopic Linear Cutter And The Endopath Ez45 No Knife Endoscopic Linear Stapler	K970720	FDA 510(k)	Class II	Active
Endo Window High Frequency Electrocautery Device, Model Ew018	K021266	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.