Medical Action Industries Recalls Epidural Kits Due to Compromised Sterility
Medical Action Industries is recalling Epidural/Pain TQC 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility."
Plain-English summary
Medical Action Industries, Inc. is recalling 1,960 units of the 'Kit: Epidural/Pain TQC 20/Cs' (REF: 82465). These kits contain Sodium Chloride Injection, 0.9%, USP 10ml ampules. The recall is being conducted because the kits contain Sodium Chloride 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. The recall includes specific lots with expiration dates ranging from April 1, 2026, to May 31, 2027. The UDI-DI for the product is 10809160367414.
Healthcare providers and consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,960
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 (8)
- UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026)
- 324586(4/1/2026)
- 327335(4/1/2026)
- 329618(9/1/2026)
- 347199(11/1/2026)
- 337283(11/1/2026)
- 350354(11/30/2026)
- 375449(5/31/2027)
Distribution
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