Stryker Sustainability Solutions
6 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Stryker Sustainability Solutions and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-08-28FDA-DeviceClass IIDisposable 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, but that may have been reprocessed, which may lead to devices not performing as intended.
- 2024-07-24FDA-DeviceClass IIREF: 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.
- 2024-07-10FDA-DeviceClass IIStryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- 2023-08-16FDA-DeviceClass IIHoverMatt, 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 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.
- 2023-05-24FDA-DeviceClass IIREF 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.
- 2023-04-05FDA-DeviceClass IIColor Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single
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.
Get notified about new Stryker Sustainability Solutions recalls
Free weekly digest. We email when a new federal recall affects Stryker Sustainability Solutions or anything else in your household.
Get the Sunday Brief