Stryker Sustainability Solutions recalls
12 official recalls and safety alerts involving Stryker Sustainability Solutions since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Stryker Sustainability Solutions or the relevant agency.
- 2026-10-14
USStryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
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…
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the state of NJ.Official notice →- 2026-09-23
- US
Stryker Sustainability Solutions recalls REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Reusable access port system may crack or seperate during use.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution including in the states of Alabama, Alaska,…Official notice → - 2026-05-20
- US
Stryker Sustainability Solutions recalls BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
FDA · DeviceStryker Sustainability SolutionsUS Nationwide and the countries of Israel and Canada.Official notice → - 2026-04-15
- US
Stryker Sustainability Solutions recalls Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker…
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.
FDA · DeviceStryker Sustainability SolutionsU.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2025-11-19
- US
Stryker Sustainability Solutions recalls HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution and OUS (foreign) to country of: Canada.Official notice → - 2024-08-28
- US
Stryker Sustainability Solutions recalls Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
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,…
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR,…Official notice → - 2024-07-24
- US
Stryker Sustainability Solutions recalls REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.Official notice → - 2024-07-10
- US
Stryker Sustainability Solutions recalls Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA · DeviceStryker Sustainability SolutionsInternational distribution to the country of Japan.Official notice → - 2023-08-16
- US
Stryker Sustainability Solutions recalls HoverMatt, 39" W x 78" L, REF: HM39SPU-B
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…
FDA · DeviceStryker Sustainability SolutionsUS: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, ILOfficial notice → - 2023-05-24
- US
Stryker Sustainability Solutions recalls REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
- 2023-04-05
- US
Stryker Sustainability Solutions recalls Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder…
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…
FDA · DeviceStryker Sustainability SolutionsUS: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE,…Official notice → - 2022-03-02
- US
Stryker Sustainability Solutions recalls REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.