FDAFDA · Food and drugs·Recall number Z-3107-2026
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
Published September 16, 2026 · Recall initiated: July 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Action Industries, Inc. 306
- Distributor
- US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
- Lot
- 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)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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