Data Foundry

Medical device recalls 2021

Feth-R-Kath Catheter — Class II medical device recall Z-1276-2021

Terminated recall by Epimed International, Inc., reported 2021-03-24, distributed nationwide. Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

Recall numberZ-1276-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmEpimed International, Inc., Johnstown, NY, United States
Recall initiated2021-02-01
Classified2021-03-18
Reported by FDA2021-03-24
Terminated2022-10-17
DistributedNationwide (US)
Quantity5,835 units
Reason classespackaging
Lot numbers11247915, 11248510, 11248553, 11248938, 11248985, 11249049
Model numbers157-1924

Product

Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

Reason for recall

Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

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-1276-2021. 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.