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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Halyard Medical Packs and Trays Recalled for Potential Seal Defect

Agency Publication Date: December 15, 2025
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Summary

AVID Medical, Inc. is recalling 728 units of several Halyard brand medical kits, including laparoscopy packs, electrophysiology (EP) lab packs, arteriogram kits, and head and neck trays. The recall was initiated because the header bags may have an incomplete seal, which can compromise the sterile barrier of the instruments inside. Consumers should stop using these products and contact the manufacturer to arrange for a return or replacement.

Risk

An incomplete seal on the packaging may allow bacteria or other contaminants to enter, compromising the sterility of the medical devices. Using non-sterile equipment during surgery or diagnostic procedures can lead to serious patient infections.

What You Should Do

  1. This recall affects Halyard brand medical products including the General Laparoscopy Pack, EP Lab PK, Midtown General Arteriogram, Major Pack, and Head and Neck Tray.
  2. Check your inventory for the following catalog and lot numbers: General Laparoscopy Pack (Catalog VAST018-10, Lot 1651776), EP Lab PK (Catalog ESJH009-03, Lot 1653112), Midtown General Arteriogram (Catalog EUHM009-01, Lot 1635477), Major Pack (Catalog JEMJ10-01, Lot 1635770), and Head and Neck Tray (Catalog EURO016-09, Lot 1655501).
  3. Stop using the recalled medical packs immediately to prevent the use of potentially non-sterile equipment.
  4. Contact AVID Medical, Inc. or your distributor directly to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Halyard General Laparoscopy Pack
Model / REF:
VAST018-10
Lot Numbers:
1651776 (Exp 3/12/2027)
UDI:
10809160452257

Quantity: 42 units

Product: Halyard EP Lab PK
Model / REF:
ESJH009-03
Lot Numbers:
1653112 (Exp 5/28/2028)
UDI:
10809160427316

Quantity: 240 units

Product: Halyard Midtown General Arteriogram
Model / REF:
EUHM009-01
Lot Numbers:
1635477 (Exp 5/29/2028)
UDI:
10809160346839

Quantity: 300 units

Product: Halyard Major Pack
Model / REF:
JEMJ10-01
Lot Numbers:
1635770 (Exp 7/26/2027)
UDI:
10809160443217

Quantity: 90 units

Product: Halyard Head and Neck Tray
Model / REF:
EURO016-09
Lot Numbers:
1655501 (Exp 3/31/2027)
UDI:
10809160461198

Quantity: 56 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98045
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: Hospitals; Medical distributors; Surgical centers
Manufactured In: United States
Units Affected: 5 products (42 units; 240 units; 300 units; 90 units; 56 units)
Distributed To: Georgia, Illinois, Nebraska, Maryland

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.