Stryker recalls non-sterile disposable tourniquet cuffs that may not hold pressure properly during setup, risking blood loss during surgery. Affected units have specific catalog numbers and lot dates.
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 non-sterile disposable tourniquet cuffs that may not hold pressure correctly when first applied, which could lead to blood loss or complications during surgery. This recall affects specific model numbers and production lots.
The tourniquet cuffs may not achieve the desired pressure or hold it properly when first set up on a patient. This can cause blood to flow into the surgical site, potentially leading to bleeding or complications during surgery.
Healthcare 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 maintain proper pressure.
Check for the catalog number 5921-218-235NS on the product. Affected units were sold with lot numbers 2022111802 through 2022121908.
Look for the catalog number 5921-218-235NS and lot numbers 2022111802 through 2022121908 on the tourniquet cuff.
The tourniquet cuffs may not hold pressure properly when first applied, which could lead to blood loss or complications during surgery.
Check the catalog number and lot numbers on the product to see if it is affected. If it is, contact Stryker for further instructions.
The recall states that improper pressure could lead to blood loss or complications during surgery, but the remedy is not specified in the record.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1344-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1344-2023 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.
