Medical Action Industries Recalls Single Shot Epidural Kits Due to Sterility Concerns
Medical Action Industries is recalling Single Shot Epidural kits containing Sodium Chloride ampules due to potentially compromised sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Medical Action Industries, Inc. is recalling specific lots of Single Shot Epidural kits (REF: 59553 and 83945B) that contain Sodium Chloride Injection, 0.9%, USP 10ml ampules. The recall is being conducted because the kits contain ampules that are subject to another recall, resulting in potentially compromised sterility.
The affected products were distributed in the United States to the states of Iowa, Virginia, Missouri, Kansas, Florida, Ohio, and Louisiana. A total of 3,606 units are involved in this recall.
Healthcare providers and consumers should stop using these specific kits and contact the manufacturer for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product may cause serious adverse health consequences or death.
The recalled product
- Product
- Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 3,606
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 (11)
- REF/UDI-DI/Lot(Expiration Date): 59553/10809160010518/330274(9/1/2026)
- 331036(11/1/2026)
- 332995(11/1/2026)
- 333957(11/1/2026)
- 338894(11/1/2026)
- 83945B/10809160444269/330827(10/10/2026)
- 330907(10/10/2026)
- 333956(11/1/2026)
- 350340(11/1/2026)
- 351266(11/30/2026)
- 373674(5/31/2027)
Distribution
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