FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard General Laparoscopy Pack recalled for incomplete header bag seal
What this means
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
The agency's original wording
Hazard
Potential for incomplete seal on header bag.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-07-29Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
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