Stryker recalls disposable tourniquet cuffs that may not hold pressure properly, leading to blood loss during surgery. Affected units have specific catalog numbers and lot dates. Consumers should contact Stryker for details.
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Stryker is recalling disposable tourniquet cuffs that may not hold pressure correctly during use, which could cause blood loss or bleeding during surgery. This risk occurs when the cuff is first applied to the patient.
The tourniquet cuffs may not achieve the correct pressure or maintain it after initial setup, which can cause blood to flow into the surgical site. This could lead to bleeding or more serious complications during surgery.
Medical professionals using the tourniquet cuffs during surgical procedures are most at risk. Patients undergoing surgery with these cuffs could experience blood loss if the cuff fails to hold pressure.
Check for the catalog number 5921-030-235NS on the product. The lot numbers 2022111804, 2022112902, 2022121909, 2022121910, 2022122603, and 2022122604 are also associated with this recall.
Look for the catalog number 5921-030-235NS and lot numbers listed above on the tourniquet cuff.
The tourniquet cuffs may not hold pressure properly during initial setup, which could lead to blood loss or bleeding during surgery.
The recall record does not specify a remedy, so contact Stryker directly for instructions.
Yes, the affected lot numbers are 2022111804, 2022112902, 2022121909, 2022121910, 2022122603, and 2022122604.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1340-2023 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.