Agency classClass IIOur severity:High FDA (Devices)·Z-1946-2021·Announced 2021-06-30

Medical Action Curved Hemostats recalled due to flaking metal risk

Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.

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: This is an FDA Class II recall involving a concrete manufacturing defect (metal flaking and discoloration) on a surgical instrument that could compromise integrity during use. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury.

Plain-English summary

Medical Action Industries, Inc. is recalling its Disposable Instrument Pack Curved Hemostat (REF 56224) due to a manufacturing defect. Hemostats are surgical instruments used to control bleeding during surgical procedures.

The affected devices have a potential for flaking metal and/or brown spots, which could affect the instrument's integrity and performance during use.

Approximately 1,940 devices (97 boxes of 20) were distributed across 16 U.S. states: Ohio, Colorado, California, Illinois, Florida, Virginia, Texas, Minnesota, Georgia, Washington, Massachusetts, Maryland, New York, Louisiana, Arizona, and Oregon. The affected batch numbers and expiration dates are: Batch 0000277592 (Exp. 10/12/2025), Batch 0000274266 (Exp. 07/21/2025), Batch 0000275098 (Exp. 08/21/2025), and Batch 0000276380 (Exp. 09/24/2025).

This is a Class II recall, as determined by the U.S. Food and Drug Administration.

The recalled product

Product: Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
Manufacturer: Medical Action Industries, Inc. 306
Category: Medical Device — Surgical Instrument
Hazard: flaking-metal
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 (8)

Batch Numbers: 0000277592
Exp. 10/12/2025
0000274266
Exp. 07/21/2025
0000275098
Exp. 08/21/2025
0000276380
Exp. 09/24/2025

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 · flaking metal