CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Esteem(TM) Synergy Stomahesive(R) recalled by ConvaTec
ConvaTec is recalling Esteem(TM) Synergy Stomahesive(R), distributed nationwide in the US. The recall was initiated on 25 Apr 2018 and the FDA has classified it as Class II.
Check your package
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-1890-2018
- FDA event ID
- 79953
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2018
- FDA classified
- 16 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2018 | Recall initiated by company | |
| 16 May 2018 | Classified by FDA | +21 days |
| 23 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Number 7F00987
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.
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