Halyard recall (AVID Medical, Inc.)
Medical deviceClass IIOngoing
Summary: AVID Medical, Inc. is recalling Halyard, EP LAB PK. Catalog Number: ESJH009-03.. Reason: Potential for incomplete seal on header bag.
What is being recalled
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Why
Potential for incomplete seal on header bag.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution to GA, IL, NE, MD. (states named: Georgia, Illinois, Maryland, Nebraska)
How to tell if yours is affected
Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0927-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 14, 2025 |
| Reported | December 24, 2025 |
| Company | AVID Medical, Inc. |
| Company location | Toano, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 240 units |
More recalls from AVID Medical, Inc. · all medical device recalls · recalls from November 2025