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Stryker Sustainability Solutions

Last updated September 17, 2026

Information

Country: US
Address: 1810 W. Drake Dr., Tempe, AZ, 85283
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3009350690
DUNS Number: —

Catalogue (56)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Baylis Medical NRG	RFX-BAY-TS	FDA UDI	Class II	Active
Biosense Webster	D134902	FDA UDI	Class II	Active
Intellanav Ablation Cable	M004 RARC01 0	FDA UDI	Class II	Active
Medtronic	2ACHC	FDA UDI	Class II	Active
Biosense Webster	D134905	FDA UDI	Class II	Unknown
Biosense Webster	D134903	FDA UDI	Class II	Active
Stryker Sustainability Solutions	4000	FDA UDI	Class II	Active
Biosense Webster	D7T20282CT	FDA UDI	Class II	Active
Philips Healthcare	014R	FDA UDI	Class II	Active
Irvine Biomdeical Inc.	D87022	FDA UDI	Class II	Unknown
Biosense Webster	D7R20P14CT	FDA UDI	Class II	Active
Stryker Sustainability Solutions	4001	FDA UDI	Class II	Active
Philips Healthcare	85900PST	FDA UDI	Class II	Active
Biosense Webster	D134906	FDA UDI	Class II	Unknown
Stryker Sustainability Solutions	4003	FDA UDI	Class II	Active
Philips Healthcare	88901	FDA UDI	Class II	Active
Irvine Biomedical Inc.	D087023	FDA UDI	Class II	Unknown
Biosense Webster	D134901	FDA UDI	Class II	Active
Irvine Biomedical Inc.	D087024	FDA UDI	Class II	Unknown
Stryker Sustainability Solutions	4002	FDA UDI	Class II	Active
Biosense Webster	D134904	FDA UDI	Class II	Active
Philips Healthcare	85900P	FDA UDI	Class II	Active
Medtronic	990066	FDA UDI	Class II	Active
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019	K230255	FDA 510(k)	Class II	Active
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider	K150538	FDA 510(k)	Class II	Active
Reprocessed 2515 Nav Variable Electrophysiology Catheter	K112292	FDA 510(k)	Class II	Active
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)	K220481	FDA 510(k)	Class II	Active
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)	K230251	FDA 510(k)	Class II	Active
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)	K241606	FDA 510(k)	U	Active
Reprocessed Ultrasound Intracardiac Echo Catheter	K121913	FDA 510(k)	Class II	Active
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)	K233471	FDA 510(k)	U	Active
Reprocessed Steerable Introducer	K123334	FDA 510(k)	Class II	Active
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)	K241758	FDA 510(k)	Class II	Active
Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology	K133672	FDA 510(k)	U	Active
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider	K172856	FDA 510(k)	Class II	Active
Reprocessed ViewFlex Xtra ICE Catheter	K182238	FDA 510(k)	Class II	Active
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)	K211138	FDA 510(k)	Class II	Active
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)	K222019	FDA 510(k)	Class II	Active
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider	K180451	FDA 510(k)	Class II	Active
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)	K220411	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Trocars and Sleeves	K201511	FDA 510(k)	Class II	Active
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2	K211140	FDA 510(k)	Class II	Active
Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent	K201756	FDA 510(k)	Class II	Active
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis	K161693	FDA 510(k)	U	Active
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled	K200205	FDA 510(k)	Class II	Active
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis	K202554	FDA 510(k)	U	Active
Reprocessed Dilating Tip Trocars	K132629	FDA 510(k)	Class II	Active
Reprocessed Stryker External Fixation Devices	K153415	FDA 510(k)	Class II	Active
Reprocessed LigaSure Maryland Jaw Sealer/Divider	K180499	FDA 510(k)	Class II	Active
Resprocessed Serfas Energy Probe	K121855	FDA 510(k)	Class II	Active

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FDA Recalls (66)

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
Apr 10, 2026	Z-2175-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2185-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2183-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2198-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2182-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2188-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2195-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2199-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2190-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2177-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2193-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2174-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2179-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2186-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2197-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2194-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2178-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2187-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2176-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2192-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2180-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2196-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2189-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2181-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2184-2026	—	open, classified	Incomplete seals on sterile product
Apr 10, 2026	Z-2191-2026	—	open, classified	Incomplete seals on sterile product
Mar 12, 2026	Z-1804-2026	—	open, classified	Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Sep 24, 2025	Z-0490-2026	—	open, classified	Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Jul 2, 2024	Z-2689-2024	—	open, classified	Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
May 31, 2024	Z-2405-2024	—	open, classified	Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
May 10, 2024	Z-2268-2024	—	open, classified	Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Jun 21, 2023	Z-2394-2023	—	open, classified	39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.
Apr 14, 2023	Z-1612-2023	—	open, classified	Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Mar 1, 2023	Z-1315-2023	—	open, classified	Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Jan 21, 2022	Z-0664-2022	—	terminated	Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Jan 19, 2021	Z-1327-2021	—	open, classified	Product was distributed without receiving regulatory clearance.
Mar 27, 2020	Z-2113-2020	—	terminated	A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
Oct 9, 2019	Z-1802-2020	—	terminated	Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Dec 17, 2018	Z-0766-2019	—	terminated	Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.
Aug 23, 2018	Z-0467-2019	—	terminated	Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Jul 27, 2018	Z-0973-2019	—	terminated	Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
Jun 19, 2018	Z-0498-2019	—	terminated	Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.
May 8, 2018	Z-2484-2018	—	terminated	Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.
Mar 29, 2018	Z-2426-2018	—	terminated	Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
Jan 2, 2018	Z-0917-2018	—	terminated	An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Jan 2, 2018	Z-0916-2018	—	terminated	An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Dec 1, 2017	Z-0272-2018	—	terminated	3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Dec 6, 2016	Z-0963-2017	—	terminated	A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Dec 6, 2016	Z-0964-2017	—	terminated	A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Nov 11, 2016	Z-0765-2017	—	terminated	An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Oct 6, 2016	Z-0380-2017	—	terminated	The EP Catheters may be mislabeled for French size during reprocessing.
Sep 19, 2016	Z-0324-2017	—	terminated	Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.
Jun 1, 2016	Z-2096-2016	—	terminated	Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
Apr 28, 2016	Z-1708-2016	—	terminated	Mislabeled for size
Apr 4, 2016	Z-1625-2016	—	terminated	Device packaging may not be sealed.
Apr 4, 2016	Z-1626-2016	—	terminated	Device packaging may not be sealed.
Dec 17, 2015	Z-0629-2016	—	terminated	Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Nov 17, 2015	Z-0478-2016	—	terminated	Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
Oct 14, 2015	Z-0235-2016	—	terminated	It was reported that packaging was not properly sealed.
Jul 10, 2015	Z-2468-2015	—	terminated	Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).
Jun 1, 2015	Z-1836-2015	—	terminated	Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Jun 1, 2015	Z-1834-2015	—	terminated	Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Jun 1, 2015	Z-1835-2015	—	terminated	Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Oct 18, 2013	Z-0340-2014	—	terminated	Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
Aug 30, 2012	Z-0840-2013	—	terminated	Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Jun 1, 2009	Z-1204-2012	—	terminated	On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09.