Halyard, EP LAB PK. Catalog Number: ESJH009-03 recallZ-0927-2026 · AVID Medical, Inc. · initiated Nov 14, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for incomplete seal on header bag.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0927-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 14, 2025
- Posted by the FDA
- Dec 15, 2025
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 240 units
- Product code
- LRO
- Distribution
- US distribution to GA, IL, NE, MD.
Product description
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Code information (models, lots, serial numbers)
Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard ESJH009-03_0003Avid Medical, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98045).
- Z-0926-2026 · Open, ClassifiedHalyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
- Z-0928-2026 · Open, ClassifiedHalyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
- Z-0929-2026 · Open, ClassifiedHalyard, MAJOR PACK. Catalog Number: JEMJ10-01.
- Z-0930-2026 · Open, ClassifiedHalyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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