FDA-Device2026-10-14Class IIPROCESSING DEFECT

AVID Medical DAVINCI LAP/GYN surgical kit recalled for manufacturing lubricant contamination

OTHERNationwide distributionMedical devices

What this means

AVID Medical has recalled DAVINCI LAP/GYN surgical kits (model WRNM037-16, lot 1663589) due to potential contamination with lubricant residue from the manufacturing process. The affected kits were distributed nationwide to facilities in Arizona, California, Florida, Maryland, Nebraska, and Texas. No injuries have been reported.

  • Check if you have received or are using kit model WRNM037-16, lot 1663589
  • Do not use the affected kit if you have it in inventory
  • Contact AVID Medical or your distributor for instructions on return or replacement
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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
30
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0101-2027

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