DAVINCI UROLOGY Medical Kit Recalled Due to Resterilization Discoloration
AVID Medical is recalling DAVINCI UROLOGY medical convenience kits because they were inadvertently resterilized, causing discoloration. The recall affects 166 units distributed domestically.
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 of a medical device with no reported illnesses or injuries. The issue is a manufacturing process control failure (inadvertent resterilization) resulting in discoloration, which represents a low-risk concern absent reported contamination or clinical consequences.
Plain-English summary
AVID Medical, Inc. is recalling the DAVINCI UROLOGY medical convenience kit due to inadvertent resterilization that caused discoloration in the kits. The affected product includes model numbers WRNM038-09, WRNM038-10, and WRNM038-11.
The recall involves 166 units distributed domestically to California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Specific lot numbers affected are 1589886, 1593087, 1606686, 1606688, 1615262, 1611133, and 1627007.
Consumers or healthcare facilities that have received this product should discontinue use and contact AVID Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- DAVINCI UROLOGY. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
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 (13)
- Model No. WRNM038-09
- WRNM038-10
- WRNM038-11
- UDI: 10809160369302
- 10809160418338
- 10809160432259
- Kit Lot No. 1589886
- 1593087
- 1606686
- 1606688
- 1615262
- 1611133
- 1627007.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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