Stryker recalls disposable tourniquet cuffs that may not hold pressure properly, risking 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, which could lead to blood loss or complications during medical procedures. This recall affects specific model numbers and production lots.
The cuffs may not achieve or maintain the required pressure when first applied to a patient. This can cause blood to flow from the surgical site, potentially leading to bleeding or more serious complications during procedures.
Medical professionals using the tourniquet cuffs during surgery are most at risk. Patients undergoing procedures with these cuffs could experience bleeding or other complications.
Check for the catalog number 5921-218-135NS on the product label. Affected units were sold with lot numbers starting with 2022111801 through 2022121206.
Reach out to Stryker Corporation for specific instructions on how to handle the recalled product.
The cuffs may not hold pressure properly when first applied, which can lead to blood loss or complications during surgery.
The affected model is the Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff with catalog number 5921-218-135NS.
Look for the catalog number 5921-218-135NS and lot numbers starting with 2022111801 through 2022121206 on the product label.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1343-2023 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.