FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical craniotomy pack recalled for potential manufacturing lubricant contamination
What this means
AVID Medical's craniotomy pack (model WRNM035-20) may contain residual lubricant from the manufacturing process. This contamination could affect the sterility and safety of the surgical kit. The recall affects a small number of units distributed across six states.
- If your facility received this craniotomy pack (model WRNM035-20, lot 1695943), do not use it
- Contact AVID Medical for return instructions and replacement
- Review your surgical supply inventory for affected lot numbers
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
10
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2027More AVID Medical recalls
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- 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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