CLASS II ONGOING Device recall · Reported 25 Mar 2026 · FDA Enforcement Report

EsteemBody Drainable recalled by ConvaTec

ConvaTec is recalling EsteemBody Drainable, distributed nationwide in the US. The recall was initiated on 16 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00768455221264 Lot: 5K00011,5K00714

Quantity recalledN/A

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-1582-2026
FDA event ID: 98455
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Ongoing
Recall initiated: 16 Feb 2026
FDA classified: 19 Mar 2026
Reported: 25 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Feb 2026	Recall initiated by company
19 Mar 2026	Classified by FDA	+31 days
25 Mar 2026	Published 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

Drainable large pouch may leak due to manufacturing issue.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

Nationwide

Questions about this recall

Why was it recalled?

Drainable large pouch may leak due to manufacturing issue.

Which lots are affected?

UDI: 00768455221264 Lot: 5K00011,5K00714

Where was it sold?

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

2 other products · FDA event 98455

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
25 Mar 2026	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide

More recalls from ConvaTec

All 54

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Esteem Body Soft Convex Urostomy recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	Aquacel Ag Surgical SP recalled by ConvaTec	ConvaTec	Potency & Assay	Nationwide
25 Mar 2026Device	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
22 Oct 2025Device	CLASS II	DuoDERM" Extra Thin dressings are highly flexible recalled by ConvaTec	ConvaTec	Foreign Material	Nationwide

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30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide