Z-0681-2019Class II

Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5...

Name: Z-0681-2019 Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5...
Creator: Medical Action Industries Inc
Published: 2018-11-27
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2018-11-27 / Terminated / root cause: packaging

FDA source

Medical Action Industries Inc began a recall of 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... on 2018-11-27. FDA classified it as Class II and gives the reason as "Potential compromise of product sterility due to breach of sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0681-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-27
Posted: 2018-12-22
Terminated: 2019-02-08
Recalling firm: Medical Action Industries, Inc. 306
Product: 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.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: Potential compromise of product sterility due to breach of sterile barrier.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 13 cases (2,600 sponges)
Distribution: Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Product codes and lots: Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0681-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0681-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)