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LAPAROSCOPY PACK. Medical convenience kit recallZ-2256-2025 · AVID Medical, Inc. · initiated Jun 11, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDA root cause category: Under Investigation by firm

What the company is doing

Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to [email protected]

Recall details

Recall number
Z-2256-2025
Status
Open, Classified
Initiated by the company
Jun 11, 2025
Posted by the FDA
Aug 4, 2025
Recalling firm
AVID Medical, Inc.
Quantity
452 units
Product code
LRO
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.

Product description

LAPAROSCOPY PACK. Medical convenience kit.

Code information (models, lots, serial numbers)

Model No. VAML025-05, WRNM007-15; UDI: 10809160387696, 10809160432235; Kit Lot No. 1580078, 1580079, 1580407, 1582536, 1585729, 1596605, 1598248, 1598249, 1607780, 1626103, 1629350, 1639643, 1627004.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97149).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page