Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number:… recallZ-2772-2026 · AVID Medical, Inc. · initiated May 19, 2026
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
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
FDA root cause category: Process change control
What the company is doing
AVID Medical notified consignees on about 05/19/2026 via email. Consignees were instructed to identify, segregate, and quarantine all impacted kits, and add the provided warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. Distributors were instructed to ensure all end-users are properly notified if affected kits have been further distributed. Customers/End-users were instructed that if they have received product from a distributor, to contact the distributor or your sales representative with any questions. Recipients were requested to complete and return the provided Recall Response Form.
Recall details
- Recall number
- Z-2772-2026
- Status
- Open, Classified
- Initiated by the company
- May 19, 2026
- Posted by the FDA
- Jul 22, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 112 kits
- Product code
- OES
- Distribution
- U.S. Nationwide distribution in the state of California.
Product description
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Code information (models, lots, serial numbers)
Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard PVHM234-01_0006Avid Medical, Inc. · Cardiac catheterization kit1 recall0 reports
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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