FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical Adult Heart Tray Shands Jacks recalled for manufacturing lubricant contamination
What this means
AVID Medical's Adult Heart Tray Shands Jacks (Model SHND419-08) may contain residual manufacturing lubricant left on the product during production. This contamination could affect the sterility or safety of the surgical instrument. The recall affects 59 kits distributed across six states.
- Check if you have Model SHND419-08 with lot numbers 1680504 or 1695337
- Do not use the affected trays until you receive instructions from AVID Medical or the FDA
- Contact AVID Medical or your distributor for replacement or further guidance
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
59
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2027More 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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