FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard General Laparoscopy Pack recalled for incomplete header bag seal
Stop using Halyard laparoscopy pack VAST018-10
Halyard's General Laparoscopy Pack (catalog number VAST018-10) may have an incomplete seal on its header bag, which could compromise the sterility of the surgical instruments inside. This affects 42 units distributed to hospitals and surgical centers in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.
- Stop using affected units immediately (lot 1651776, expiration 3/12/2027)
- Check your inventory for catalog number VAST018-10 and lot number 1651776
- Contact your distributor or Halyard/AVID Medical for return or replacement instructions
- Review your surgical records to identify any patients who may have received instruments from affected packs
Hazard
Potential for incomplete seal on header bag.
Sold states
US distribution to GA, IL, NE, MD.
Affected count
42 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2026More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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