Stryker Sustainability Solutions recalls
Stryker Sustainability Solutions appears in 72 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 72 |
|---|---|
| Published | 2013-02-27 to 2026-10-14 |
| By agency | FDA Device (72) |
| By classification | Class II (70), Class I (2) |
| By status | ongoing (42), terminated (30) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
FDA Device · Class II · 2026-10-14 · Stryker Sustainability Solutions
Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma format… - REF:2B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - REF:B11LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - REF:B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - REF:B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - REF:2B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - REF:B12LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
Reason: Reusable access port system may crack or seperate during use. - BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401652
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic Tip Steerable, Product Number 200344
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401582
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BW Webster Duo-Decapolar, Product Number D728260RT
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic Tip Steerable, Product Number 6DYNTP001
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401575
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401923
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401908
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401914
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic Deca Steerable, Product Number 201101
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Medtronic Marinr Steerable, Product Number 72402
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401915
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic XT Steerable, Product Number 201104
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD EP XT Steerable, Product Number 200794
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - CS Uni-Directional w Auto ID, Product Number D135303
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD Dynamic Tip Steerable, Product Number 200131
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - CS Uni-Directional w Auto ID, Product Number D135304
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - BARD EP XT Decapolar Steerable, Product Number 201007
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401905
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401904
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401581
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Daig Livewire Steerable, Product Number 401932
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions
Reason: Incomplete seals on sterile product - Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solu…
FDA Device · Class II · 2026-04-15 · Stryker Sustainability Solutions
Reason: 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. - HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
FDA Device · Class II · 2025-11-19 · Stryker Sustainability Solutions
Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. - Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
FDA Device · Class II · 2024-08-28 · Stryker Sustainability Solutions
Reason: 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,… - REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
FDA Device · Class II · 2024-07-24 · Stryker Sustainability Solutions
Reason: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. - Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Len…
FDA Device · Class II · 2024-07-10 · Stryker Sustainability Solutions
Reason: Diagnostic electrophysiology (EP) catheters do not meet testing requirements. - HoverMatt, 39" W x 78" L, REF: HM39SPU-B
FDA Device · Class II · 2023-08-16 · Stryker Sustainability Solutions
Reason: 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 exerte… - REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
FDA Device · Class II · 2023-05-24 · Stryker Sustainability Solutions
Reason: Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. - Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu…
FDA Device · Class II · 2023-04-05 · Stryker Sustainability Solutions
Reason: 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… - REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
FDA Device · Class II · 2022-03-02 · Stryker Sustainability Solutions
Reason: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. - Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2021-04-07 · Stryker Sustainability Solutions
Reason: Product was distributed without receiving regulatory clearance. - Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only…
FDA Device · Class II · 2021-02-03 · Stryker Sustainability Solutions
Reason: 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 affe… - Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuf…
FDA Device · Class II · 2020-05-06 · Stryker Sustainability Solutions
Reason: Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force. - Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue a…
FDA Device · Class II · 2019-03-13 · Stryker Sustainability Solutions
Reason: 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… - BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed elect…
FDA Device · Class II · 2019-01-30 · Stryker Sustainability Solutions
Reason: 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… - Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Descriptio…
FDA Device · Class II · 2018-12-05 · Stryker Sustainability Solutions
Reason: 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… - Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the c…
FDA Device · Class II · 2018-11-21 · Stryker Sustainability Solutions
Reason: 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. - Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMON…
FDA Device · Class II · 2018-07-25 · Stryker Sustainability Solutions
Reason: 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 genera…