Haylard UNIV IMAGING BIOPSY TRUCUSTOM recallZ-3154-2026 · AVID Medical, Inc. · initiated Aug 10, 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
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, Segregate, and Quarantine all impacted kits listed. 2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return.
Recall details
- Recall number
- Z-3154-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2026
- Posted by the FDA
- Sep 16, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 340 kits
- Product code
- OES
- Distribution
- Domestic: IL, NC, VA, WY;
Product description
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Code information (models, lots, serial numbers)
Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard VARV042-03_0008Avid Medical, Inc. · Cardiac catheterization kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99758).
- Z-3151-2026 · Open, ClassifiedHaylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
- Z-3152-2026 · Open, ClassifiedHaylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
- Z-3153-2026 · Open, ClassifiedHaylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
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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