Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise
Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.
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: The recall involves a potential sterility breach in a medical device used inside the body, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medical Action Industries Inc is recalling 13 cases (2,600 sponges) of Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles. The recall is due to a potential compromise of product sterility caused by a breach of the sterile barrier.
The affected product is identified by Model Number 403, Lot Number 1806JK305A, and Expiration Date 06/20/2023. The devices were distributed in five U.S. states: Minnesota, Washington, New York, Massachusetts, and Michigan. No product was distributed outside of the United States.
Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structures to control bleeding, absorb fluid, or protect organs from abrasions, drying, or contamination. Users should stop using the affected sponges and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Medical Action Industries Inc
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 (5)
- Model Number: 403
- Lot Number: 1806JK305A
- Expiration Date: 06/20/2023
- UDI (Pack): 10809160000113
- UDI (Case): 50809160000111
Distribution
Related recalls
Same manufacturer · Medical Action Industries Inc
See all →- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
FDA (Devices) · 2019-04-03
- HighMedical Action Industries Recalls Blue OR Towels Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateMedical Action Industries Recalls Blue OR Towels Due to Lint Presence
FDA (Devices) · 2017-05-24
- ModerateMedical Action Industries Recalls Sterile Operating Room Towels Due to Lint
FDA (Devices) · 2017-05-24
- ModerateMedical Action Industries Recalls PICC/CVC Dressing Kits Due to Misbranding
FDA (Devices) · 2016-03-09
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
FDA (Devices) · 2019-04-03
- SevereCurity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
FDA (Devices) · 2016-06-08
- HighLaparotomy Sponges recalled for incomplete sterilization and missing RF detection
FDA (Devices) · 2024-03-27
- HighAmerican Surgical Ray-Cot Sponges Recalled for Sterility Compromise
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- SevereKerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
FDA (Devices) · 2016-06-08