Stryker recalls disposable tourniquet cuffs that may not hold pressure properly, risking blood loss during surgery. Affected units include specific catalog numbers and lot dates. 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 surgery, potentially causing blood loss or complications. This affects specific model numbers and production lots sold in recent months.
The cuffs may not achieve or maintain the required pressure when first applied to a patient's limb. This can lead to blood flow not being properly blocked, increasing the risk of bleeding during surgery. In very rare cases, this could cause serious complications.
Healthcare professionals using the tourniquet cuffs during surgical procedures are most at risk. Patients undergoing surgery with these cuffs could experience blood loss or complications.
Check for the catalog number 5921-030-135NS on the product label. Affected units were sold with lot numbers 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, or 2022122602.
Look for the catalog number 5921-030-135NS on the tourniquet cuff label.
Reach out to Stryker Corporation for further instructions on handling affected units.
The cuffs may not hold pressure properly when first applied, potentially causing blood loss or complications during surgery.
The affected model is the Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff with catalog number 5921-030-135NS.
Check for the catalog number 5921-030-135NS and lot numbers 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, or 2022122602.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1339-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1339-2023 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.
