Plastic Tenaculum Surgical Instruments Recalled for Unconfirmed Manufacturing Standards
Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.
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 is an FDA Class II recall for a surgical instrument where the manufacturer cannot confirm manufacturing standards compliance. No injuries or illnesses have been reported, and the hazard remains theoretical pending further investigation.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling plastic tenaculum surgical instruments (Part Number 356T). The tenaculum is used in surgical and medical procedures.
The recall was issued because the manufacturer cannot confirm that the devices were produced in accordance with required design and manufacturing standards. This is classified as a Class II recall by the U.S. Food and Drug Administration.
Approximately 2,483 kits were distributed nationwide to healthcare facilities across the United States and to Canada.
The recalled product
- Product
- Tenaculum, Plastic
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- Affected units
- 2,483
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 (1)
- Part Number: 356T
Distribution
Part of a larger recall action
This product is one of 6 recalled by Stradis Medical, LLC dba Stradis Healthcare 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.
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