Data Foundry

Medical device recalls 2026

Kit: Single Shot Epidural 20/Cs — Class I medical device recall Z-3107-2026

Ongoing recall by Medical Action Industries, Inc. 306, reported 2026-09-16, distributed in FL, IA, KS, MO, OH, VA. Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised

Recall numberZ-3107-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedical Action Industries, Inc. 306, Arden, NC, United States
Recall initiated2026-07-23
Classified2026-09-09
Reported by FDA2026-09-16
DistributedFL, IA, KS, MO, OH, VA
Quantity3,606
Reason classessterility
UPC / GTIN / UDI-DI10809160010518, 10809160444269
Model numbers59553, 83945B

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 for recall

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3107-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.