Stryker recalls specific Color Cuff tourniquet cuffs that may tear or have faulty O-rings, causing pressure loss and potential bleeding during medical procedures.
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.
Stryker is recalling certain Color Cuff tourniquet cuffs that can tear or have faulty O-rings, leading to pressure loss and possible bleeding during medical procedures. This affects specific sizes and colors sold in the U.S. and Canada.
The cuffs may tear during use or have a pinched/unseated O-ring at the connection point, causing pressure loss. This can lead to blood flow returning to the surgical site, resulting in bleeding or other complications.
Medical professionals using these cuffs during surgeries or procedures are most at risk. Patients undergoing operations with these cuffs could experience bleeding complications.
Check for the following: Royal Blue or Purple color, sizes 18, 30, or 34, with the reference numbers listed in the recall notice. The product was sold in the U.S. and Canada.
Identify the reference number and color to confirm if your cuff is recalled.
Reach out to Stryker for guidance on the next steps if your cuff is affected.
The recall is due to increased reports of tourniquet cuffs not holding pressure because of fabric tearing or faulty O-rings, which can lead to bleeding during procedures.
Check for the specific reference numbers and colors listed in the recall notice: Royal Blue or Purple, sizes 18, 30, or 34.
Contact Stryker directly for guidance on the next steps if your cuff is affected.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1315-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1315-2023 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.
