CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report

EsteemBody Soft Convex, Drainable, Product codes recalled by ConvaTec

ConvaTec is recalling EsteemBody Soft Convex, Drainable, distributed nationwide in the US. The recall was initiated on 19 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 423643, UDI/DI 768455203925, Lot Numbers 3L03391; b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005; c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670; d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230; e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004; f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989; g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674; h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114; i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669; j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542; k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021; l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786; m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540; n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539; o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541; p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029; q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958; r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888; s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022; t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023
Quantity recalled6709 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1350-2024
FDA event ID
94121
Recalling firm
ConvaTec, Greensboro, NC
Classification
Class II
Status
Ongoing
Recall initiated
19 Feb 2024
FDA classified
21 Mar 2024
Reported
27 Mar 2024
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

19 Feb 2024Recall initiated by company
21 Mar 2024Classified by FDA+31 days
27 Mar 2024Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Italy, UK.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

a) 423643, UDI/DI 768455203925, Lot Numbers 3L03391; b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005; c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670; d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230; e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004; f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989; g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674; h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114; i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669; j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542; k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021; l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786; m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540; n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539; o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541; p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029; q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958; r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888; s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022; t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Italy, UK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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