FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical DAVINCI TRUCUSTOM BUNDLE recalled for manufacturing lubricant contamination
What this means
AVID Medical's DAVINCI TRUCUSTOM BUNDLE kits (models SAMM064-27 and SAMM064-28) may contain residual lubricant from the manufacturing process. The contamination affects specific lot numbers of these surgical kits distributed across six U.S. states.
- Check if you have one of the affected lot numbers: SAMM064-27 lots 1657586, 1658104, 1671251, or SAMM064-28 lot 1698700.
- Do not use affected kits until you receive instructions from AVID Medical.
- Contact AVID Medical immediately if you have an affected kit.
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
144
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2027More AVID Medical recalls
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- 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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