FDA Medical devices recall ·
Kit: Single Shot Epidural 20/Cs recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-3107-2026
- Date
- (initiated July 23, 2026)
- Company / brand
- Medical Action Industries, Inc. 306
25 Heywood Rd, Arden, NC, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3,606
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
Distribution
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
States: Florida Iowa Kansas Missouri Ohio Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-3107-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.