Agency classClass IIOur severity:High FDA (Devices)·Z-1949-2021·Announced 2021-06-30

FDA Recalls Medical Action Minor Procedure Trays for Flaking Metal on Hemostats

Medical Action Industries is recalling 31 cases of Minor Procedure Trays because hemostats in the kits may have flaking metal or brown spots that could compromise sterile surgical procedures.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a risk-of-harm medical device. The potential for metal flaking on surgical hemostats presents a theoretical hazard that could compromise sterile procedure integrity, but no injuries or illnesses have been reported, meeting the criterion for High severity.

Plain-English summary

Medical Action Industries Inc. is recalling its Minor Procedure Tray (REF 61214) due to potential flaking metal and brown spots on the hemostats included in the kits. The hemostats may be sold as individual units or packaged within the procedure trays.

The flaking metal and discoloration pose a risk during minor surgical procedures, as loose metal fragments could contaminate the sterile field or compromise the function of the instrument. No injuries or illnesses have been reported to date.

The recall affects 31 cases containing 20 units each, distributed nationwide to healthcare facilities in Ohio, Colorado, California, Illinois, Florida, Virginia, Texas, Minnesota, Georgia, Washington, Massachusetts, Maryland, New York, Louisiana, Arizona, and Oregon. The affected batches have lot numbers 0000275137 (expiration 05/29/2022) and 0000276914 (expiration 02/01/2023).

Healthcare providers who have received these trays should stop using them and contact Medical Action Industries for return and replacement instructions.

The recalled product

Product: Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
Manufacturer: Medical Action Industries, Inc. 306
Category: Medical Device — Surgical / Hemostasis
Hazard: metal-flaking
device-defect

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 (4)

Batch Numbers: 0000275137
Exp. 05/29/2022
0000276914
Exp. 02/01/2023

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Medical Action Industries, Inc. 306 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 5 products in this recall →

Same manufacturer · Medical Action Industries, Inc. 306

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Same hazard · metal flaking