CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

Laparotomy Sponge, XR No Loop, Single-Use, Sterile recalled

Medical Action Industries is recalling Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands, distributed in Massachusetts, Michigan, Minnesota, New York, Washington. The recall was initiated on 27 Nov 2018 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled13 cases (2,600 sponges)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0681-2019
FDA event ID: 81640
Recalling firm: Medical Action Industries, Arden, NC
Classification: Class II
Status: Terminated
Recall initiated: 27 Nov 2018
FDA classified: 22 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

27 Nov 2018	Recall initiated by company
22 Dec 2018	Classified by FDA	+25 days
2 Jan 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

Massachusetts Michigan Minnesota New York Washington

Questions about this recall

Is Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands recalled?

Yes. Medical Action Industries recalled Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands on 27 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0681-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medical Action Industries

All 14

Reported	Class	Recall	Company	Reason	Where
3 Apr 2019Device	CLASS II	Laparotomy Sponge with the following product description recalled	Medical Action Industries	Sterility	Nationwide
6 Jun 2018Device	CLASS II	Blue OR Towel Non X-Ray Detectable recalled by Medical Action Industries	Medical Action Industries	Sterility	Nationwide
24 May 2017Device	CLASS II	Blue OR Towels, X-Ray Detectable, Sterile recalled	Medical Action Industries	Sterility	AR, IN, NV
24 May 2017Device	CLASS II	White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk;/Cs recalled	Medical Action Industries	Sterility	AR, IN, NV
9 Mar 2016Device	CLASS II	PICC/CVC Secure Dressing Change kit recalled	Medical Action Industries	Labeling Errors	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide