The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0126-2022·Announced 2021-10-27

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.

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: 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
Category
Medical Device — Surgical Instrument
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

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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.

See all 6 products in this recall →

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