Medline recalls sterile surgical drapes labeled as ORTHO TRAUMA CDS and other total knee/hip/spine products due to potential pouch packaging breach risking loss of sterility. Affected items have specific model numbers and lot dates.
Potential breach in pouch packaging which could lead to loss of sterility.
Medline is recalling sterile surgical drapes used in orthopedic procedures because their packaging might not stay sealed properly, which could lead to loss of sterility during surgery. This means the drapes might not be safe for use in medical procedures if the packaging is compromised.
The pouch packaging may have a breach that could allow contamination, meaning the drapes might not remain sterile during surgery. This could lead to infections or other complications if the drapes are used without proper sterility.
Patients and medical professionals who have received these sterile surgical drapes for orthopedic procedures. The risk is highest for those using the drapes in surgical settings where sterility is critical.
Check for drapes labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, or SPINE. The product has specific model numbers and lot dates listed in the recall notice.
Look for the product name and model numbers listed in the recall notice to confirm if your drapes are affected.
The recall is happening because there is a potential breach in the pouch packaging that could lead to loss of sterility, which might cause contamination during surgery.
The recall notice does not specify a remedy, so you should check the product label to see if it matches the affected items listed in the recall. If it does, contact Medline for further instructions.
The recall indicates a potential risk of loss of sterility, so they should not be used until the issue is resolved by the manufacturer.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1370-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1370-2025 from Medline. 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.