FDA recall, , High risk
Medical Action Industries Epidural Kits
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Summary by Recall Canary from the FDA notice
What happened
Medical Action Industries, Inc. 306, of Arden, North Carolina, recalled kits containing Sodium Chloride Injection, 0.9%, USP 10ml ampules due to potentially compromised sterility. The kits are Epidural/Pain TQC 20/Cs, REF: 82465, and Single Shot Epidural 20/Cs, REF: 59553 and REF: 83945B. The recall began July 23, 2026, and was added to the FDA's Enforcement Report on September 9, 2026. The products were distributed in Iowa, Virginia, Missouri, Kansas, Florida, Ohio, and LS.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
- UDI-DI
- 10809160367414
- Lot code
- 322200
- 324586
- 327335
- 329618
- 347199
- 337283
- 350354
- 375449
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
- UDI-DI
- 10809160010518
- 10809160444269
- Lot code
- 59553
- 330274
- 331036
- 332995
- 333957
- 338894
Recall details
- Company began the recall
- Company
- Medical Action Industries, Inc. 306Arden, North Carolina
- Hazard
- Sterility problem
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99613
- Recall numbers
- Z-3106-2026 to Z-3107-2026
All recalls from Medical Action Industries, Inc. 306
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
