Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x… recallZ-0681-2019 · Medical Action Industries Inc · initiated Nov 27, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Medical Action Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Medical Action Industries notified customers on about 11/27/2018 via "URGENT MEDICAL DEVICE NOTICE OF RECALL" Letter. Consignees were instructed to immediately examine inventory, quarantine all affected product, notify customers if the affected product was further distributed, and complete and return the recall response form. For consignees with affected product in inventory, Medical Action Industries will issue a Returned Materials Authorization (RMA) to return affected product.

Recall details

Recall number: Z-0681-2019
Status: Terminated
Initiated by the company: Nov 27, 2018
Recalling firm: Medical Action Industries Inc
Quantity: 13 cases (2,600 sponges)
Product code: GDY
Distribution: Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

Product description

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.

Code information (models, lots, serial numbers)

Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Medical Action Industries 403
Medical Action Industries Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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