Avid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
Avid Medical, Inc. is recalling 30 DAVINCI LAP/GYN kits (Model WRNM037-16) because they may be contaminated with a lubricant used during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as Class II, indicating a potential for temporary or medically reversible adverse health consequences. The source identifies the hazard as potential contamination with a manufacturing lubricant but does not report any illnesses, injuries, or deaths.
Plain-English summary
Avid Medical, Inc. is recalling 30 units of the DAVINCI LAP/GYN product, Model/Item Number (Kit) WRNM037-16. The recall is due to the potential for the product to be contaminated with a lubricant used during the manufacturing process.
The affected kits have the UDI-DI 10809160468913 and Kit Lot Number 1663589. They contain a recalled supplier component (A942216) with Supplier Lot Number NGKT3375. The products were distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses, injuries, or deaths associated with the contamination.
The recalled product
- Product
- DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 30
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 (5)
- Model/Item Number (Kit): WRNM037-16
- UDI-DI: 10809160468913
- Kit Lot Numbers: 1663589
- Recalled Supplier Component (in kit): A942216
- Recalled Supplier Lot Number (in kit): NGKT3375
Distribution
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