Data Foundry

Medical device recalls 2024

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System — Class II medical device recall Z-1276-2024

Ongoing recall by ConvaTec, Inc, reported 2024-03-13, distributed in AK, CA, FL, IL, IN, MI, NE, NJ…. The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupl

Recall numberZ-1276-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmConvaTec, Inc, Greensboro, NC, United States
Recall initiated2024-01-17
Classified2024-03-07
Reported by FDA2024-03-13
DistributedAK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX
Countries outside the USCA
Quantity1,715 units
UPC / GTIN / UDI-DI00768455116096
Lot numbers2C02496
Model numbers3/4, 416938, 45MM

Product

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

Reason for recall

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

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-1276-2024. 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.