Device recall: Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Fl

FDA enforcement event 79953 · Class II · initiated 25 Apr 2018 · status Terminated · terminated 27 Feb 2023

DeviceVoluntary: Firm initiated1 product recordGreensboro, NC

ConvaTec, Inc (Greensboro, NC) initiated this device recall on 25 Apr 2018; FDA lists 1 product record under event 79953, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 27 Feb 2023. Initiation: voluntary: firm initiated. ConvaTec, Inc has 23 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ConvaTec, Inc, Greensboro, NC.

Reason for recall

"It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label."

Distribution

"US Nationwide Distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1890-2018	Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.	200 boxes of 10	Class II	Terminated	23 May 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

23events on this register for the firm

Other enforcement events for ConvaTec, Inc

Initiated	Product (first record)	Type	Class	Records
6 Jul 2026	Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 42	Device	Class II	1
8 Jun 2026	Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R	Device	Class II	1
16 Feb 2026	Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm	Device	Class II	3
29 Aug 2025	DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud	Device	Class II	1
29 Nov 2024	Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh	Device	Class II	1
27 Feb 2024	ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/im	Device	Class II	1
19 Feb 2024	Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 42	Device	Class II	1
17 Jan 2024	ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.	Device	Class II	1
15 Nov 2022	ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive	Device	Class II	1
16 Aug 2022	ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu	Device	Class II	4

All 23 events for ConvaTec, Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Feb 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.