FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical laparoscopic prostatectomy kit recalled for manufacturing lubricant contamination
What this means
AVID Medical's laparoscopic prostatectomy kit (Model NIHB0036-07) may contain residual lubricant from the manufacturing process. The contamination affects a limited number of kits distributed across six U.S. states. No injuries have been reported.
- If your facility received kit Model NIHB0036-07 with lot number 1657751, contact AVID Medical or your distributor immediately
- Do not use affected kits until you receive guidance from AVID Medical
- Check your inventory for the specific lot number and component (A942216, lot NGKT3375)
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
15
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2027More 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 Endovascular Pack recalled for manufacturing lubricant contamination
- FDA-Device2026-10-14AVID Medical DAVINCI LAP/GYN surgical kit recalled for manufacturing lubricant contamination
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