Official recall notice
FDA DeviceClass INotable
FDA Recall: Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Contain
- Recall date
- 2026-09-16
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Product description
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Affected products
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)