Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Laparotomy Sponge Recalled by Medical Action Industries Inc Due to Potential compromise of product sterility due to breach...

Date: November 27, 2018
Company: Medical Action Industries Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medical Action Industries Inc directly.

Affected Products

Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.

Quantity: 13 cases (2,600 sponges)

Why Was This Recalled?

Potential compromise of product sterility due to breach of sterile barrier.

Where Was This Sold?

This product was distributed to 5 states: MA, MI, MN, NY, WA

Affected (5 states)Not affected

About Medical Action Industries Inc

Medical Action Industries Inc has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report