CLASS II ONGOING Device recall · Reported 2 Nov 2022 · FDA Enforcement Report

Esteem+ Durahesive Plus, Drainable, 3/4 recalled by ConvaTec

ConvaTec is recalling Esteem+ Durahesive Plus, Drainable, 3/4-2, 19, distributed nationwide in the US. The recall was initiated on 16 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI: 768455115334, Batch Number: 2A02671
Quantity recalled182 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-0128-2023
FDA event ID
90856
Recalling firm
ConvaTec, Greensboro, NC
Classification
Class II
Status
Ongoing
Recall initiated
16 Aug 2022
FDA classified
24 Oct 2022
Reported
2 Nov 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

16 Aug 2022Recall initiated by company
24 Oct 2022Classified by FDA+69 days
2 Nov 2022Published in enforcement report+9 days

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

Reason for recall

impaired functionality of the release liner

Product as listed by the FDA

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

impaired functionality of the release liner

Which lots are affected?

UDI/DI: 768455115334, Batch Number: 2A02671

Where was it sold?

US Nationwide distribution.

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.

Other products in this recall event

3 other products · FDA event 90856

This product is part of a recall event; the main page for the event is Active Life, One-Piece Drainable, 3/4 recalled by ConvaTec.

ReportedClassRecallCompanyReasonWhere
CLASS IIActive Life, One-Piece Drainable, 3/4 recalled by ConvaTecConvaTecOtherNationwide
CLASS IIEsteem+ Durahesive Plus, Drainable, 3/4 recalled by ConvaTecConvaTecOtherNationwide
CLASS IIActive Life, One-Piece Drainable, 3/4 recalled by ConvaTecConvaTecOtherNationwide

More recalls from ConvaTec

All 54
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DeviceCLASS IIEsteem Body Soft Convex Urostomy recalled by ConvaTecConvaTecPackaging DefectsNationwide
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DeviceCLASS IIEsteemBody Drainable recalled by ConvaTecConvaTecPackaging DefectsNationwide
DeviceCLASS IIEsteemBody Drainable recalled by ConvaTecConvaTecPackaging DefectsNationwide
DeviceCLASS IIEsteemBody Drainable recalled by ConvaTecConvaTecPackaging DefectsNationwide

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