AVID Medical, Inc. recalls LAPAROSCOPY PACK. Medical convenience kit.
Reason for recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
LAPAROSCOPY PACK. Medical convenience kit.
Lot / code information
- Model
- VAML025-05, WRNM007-15
- UDI
- 10809160387696, 10809160432235; Kit
- Lot #
- 1580078, 1580079, 1580407, 1582536, 1585729, 1596605, 1598248, 1598249, 1607780, 1626103, 1629350, 1639643, 1627004
What the firm 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 complaints@owens-minor.com
DistributionShow detailsHide
Domestic: CA, IL, MD, OH, PA, TX, WA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2256-2025
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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