Recall archive / FDA device enforcement
Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride... — FDA record Z-3107-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Classification
- Class I
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 3,606
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3107-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 16, 2026
- Recall initiation date
- Jul 23, 2026
- Center classification date
- Sep 9, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.