FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical gynecologic surgery kits recalled for manufacturing lubricant contamination
What this means
AVID Medical gynecologic laparoscopy and laparotomy surgical kits may contain residual manufacturing lubricant. The contamination occurred during the production process and affects specific kit lot numbers distributed across six U.S. states.
- Check if your facility has kits with model WRNM002-15 (lot 1666722) or FBCH108-03 (lots 1659079, 1696378).
- Do not use affected kits until you receive guidance from AVID Medical or your supplier.
- Contact AVID Medical for instructions on return, replacement, or verification of your kits.
The agency's original wording
Hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Affected count
134
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2027More AVID Medical recalls
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- FDA-Device2026-10-14AVID Medical PACK OPEN HEART CFH recalled for potential manufacturing lubricant contamination
- FDA-Device2026-10-14AVID Medical laparoscopic prostatectomy kit recalled for manufacturing lubricant contamination
- FDA-Device2026-10-14AVID Medical Endovascular Pack recalled for manufacturing lubricant contamination
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