Recalls / —

—#217485

Product

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.

Why it was recalled

Potential for incomplete seal on header bag.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.

Recalling firm

Firm

AVID Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

US distribution to GA, IL, NE, MD.

Timeline

Recall initiated

2025-11-14

Posted by FDA

2025-12-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.