CooperSurgical recalls Colpo-Pneumo Occluder Part CPO-6 with specific lot numbers due to potential infection risk from compromised sterile pouch seals. Affected patients should contact the manufacturer for guidance.
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
CooperSurgical is recalling a specific type of medical device called the Colpo-Pneumo Occluder Part CPO-6. The recall is because the sterile pouch seal might not be secure, which could lead to infections during medical procedures.
The sterile pouch seal might become compromised, meaning it could not properly protect the device from contamination. This increases the risk of infection during medical procedures if the device is used without a secure seal.
Patients using this medical device for procedures like pelvic surgeries are most at risk. The recall affects specific lot numbers produced between 2024 and 2025.
Check the lot number on the device packaging. The affected lots include 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, and 248112.
Look for the lot number on the product packaging to determine if it is affected.
The seal of the sterile pouch may be compromised, increasing the risk of infection during medical procedures.
Check the lot number on the packaging. If it matches the affected lots listed, contact CooperSurgical for guidance.
The recall record does not specify a remedy or fix for this product.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0098-2019 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0098-2019 from CooperSurgical. 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.