FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
- Recall number
- Z-2247-2025
- Recalling firm
- AVID Medical, Inc.
- Product
- GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
- Status
- Open, Classified
- Initiated
- 2025-06-11
- Posted
- 2025-08-04
- Terminated
- not on file
- Reason
- CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Root cause
- Under Investigation by firm
- Action
- 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 complaints@owens-minor.com
- Quantity
- 574 units
- Distribution
- Domestic: CA, IL, MD, OH, PA, TX, WA.
- Lot, serial or model codes
- Model No. EURO010-08, USAR042-17, WILF006-29; UDI: 10809160414309, 10809160400586, 10809160429914, 10809160431108; Kit Lot No. 1616570, 1581675, 1594938, 1597550, 1600846, 1620149, 1620150, 1620151, 1622920.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28