Convatec EsteemBody Soft Convex — Class II medical device recall Z-1350-2024
Ongoing recall by ConvaTec, Inc, reported 2024-03-27, distributed nationwide. Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Sof
| Recall number | Z-1350-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2024-02-19 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, IT |
| Quantity | 6,709 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00768455203925, 00768455203932, 00768455203956, 00768455203963, 00768455203970, 00768455204007, 00768455204014, 00768455204021, 00768455204038, 00768455204052, 00768455204069, 00768455204076, 00768455204083, 00768455204090, 00768455204106, 00768455204137, 00768455204144, 00768455204151, 00768455204168 |
| Lot numbers | 3K03888, 3L00958, 3L02230, 3L03391, 3L03669, 3L03670, 3L04004, 3L04005, 3L04114, 3L04674, 3L04989, 3M00021, 3M00022, 3M00023, 3M00029, 3M00786, 3M01539, 3M01540, 3M01541, 3M01542 |
| Model numbers | 423643, 423644, 423645, 423646, 423647, 423648, 423651, 423652, 423653, 423654, 423656, 423657, 423658, 423659, 423660, 423661, 423664, 423665, 423666, 423667 |
Product
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
Reason for recall
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
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-1350-2024. 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.