FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical GYN laparoscopy pack recalled for potential lubricant contamination
What this means
AVID Medical's GYN laparoscopy pack (model NAMC436-12) may contain residual lubricant from the manufacturing process. This contamination could affect the sterility and safety of the surgical kit. A total of 28 kits were distributed across six states.
- Check if you have kit model NAMC436-12 with lot number 1697826.
- Do not use the kit if you have it in inventory.
- Contact AVID Medical for return or replacement instructions.
- Report any use or patient effects to AVID Medical and the FDA.
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
28
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2027More AVID Medical recalls
- FDA-Device2026-10-14AVID Medical EURO053 plastic tray recalled for manufacturing lubricant contamination
- FDA-Device2026-10-14AVID Medical HEART PREP TRAY recalled for potential manufacturing lubricant contamination
- 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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