Medical Action Industries Recalls Laceration Kits Due to Seal Defects
Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
What this means for you
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 risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the High severity criteria for theoretical risk without confirmed illness.
Plain-English summary
Medical Action Industries, Inc. is recalling sterile laceration kits (Model 68718, Lot 187198) because some units may have incomplete seals. This defect might compromise the sterility of the kits, posing a risk of infection if used.
The recall involves 474 cases (9,480 individual kits) that were distributed in Arkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia. The affected products have an expiration date of 12/1/2016.
Healthcare facilities and consumers should stop using these kits and contact Medical Action Industries for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
- Category
- Medical Device — Surgical Kits
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 (3)
- Model number: 68718
- Lot number: 187198
- Exp. Date: 12/1/2016.
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medical Action Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →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 Laparotomy Sponges Due to Sterility Compromise
FDA (Devices) · 2019-01-02
- HighMedical Action Industries Recalls Blue OR Towels Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateMedical Action Industries Recalls Sterile Operating Room Towels Due to Lint
FDA (Devices) · 2017-05-24
- ModerateMedical Action Industries Recalls Blue OR Towels Due to Lint Presence
FDA (Devices) · 2017-05-24
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12