Laparoscopic gynecology kit recalled for improper resterilization and discoloration
AVID Medical is recalling laparoscopic gynecology kits due to improper resterilization that caused discoloration. The recall affects 18 units distributed across several states.
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: This FDA Class II recall involves a manufacturing defect (improper resterilization) with no reported illnesses, injuries, or deaths. The hazard is a quality and sterilization process failure, representing a moderate-level manufacturing issue without reported patient harm.
Plain-English summary
AVID Medical, Inc. is recalling LAPAROSCOPIC GYN. Medical convenience kits due to a manufacturing defect. The CLEARIFY VISUALIZATION SYSTEM component in the kits was inadvertently resterilized, causing discoloration.
The affected product is Model No. EURO011-08 with Kit Lot No. 1613056 and UDI 10809160414248. A total of 18 units were distributed to healthcare facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Healthcare facilities that received these kits should verify their lot numbers. If you have received affected kits, contact AVID Medical, Inc. for further instructions on return, replacement, or verification.
The recalled product
- Product
- LAPAROSCOPIC GYN. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- improper-sterilization
- 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 (3)
- Model No. EURO011-08
- UDI: 10809160414248
- Kit Lot No. 1613056.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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