LAVH packs contain an inadvertently resterilized visualization system
LAVH Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 292 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over discoloration from an unintended resterilization, with no device defect or clinical consequence stated in the source.
Plain-English summary
The LAVH Pack medical convenience kit, model number USAR053-11, UDI 10809160372357, is being recalled. The action covers 292 units across kit lots including 1578109, 1585712, 1597106 and 1601742.
The stated reason is that the Clearify Visualization System was inadvertently resterilized in the kits, causing discoloration. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was domestic, to California, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and kit lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- LAVH PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model No. USAR053-11
- UDI: 10809160372357
- Kit Lot No. 1578109
- 1585712
- 1597106
- 1601742
- 1601643
- 1607925
- 1612044
- 1621429
- 1637117.
Distribution
Part of a larger recall action
This product is one of 24 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- HighAVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Halyard Kits Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- ModerateHalyard Total Joint Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits Due to Latex Labeling Error
FDA (Devices) · 2026-09-02
Same hazard · resterilization
See all →- HighGeneral and laparotomy packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCardiovascular procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighDilation and curettage packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCardiac catheterization packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCentral line insertion kits recalled after being sterilized more than once
FDA (Devices) · 2025-10-22