CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Aquacel Foam Ag Adhesive, wound dressing advesive recalled by ConvaTec
ConvaTec is recalling Aquacel Foam Ag Adhesive, wound dressing advesive, distributed nationwide in the US. The recall was initiated on 15 Nov 2022 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-0723-2023
- FDA event ID
- 91081
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Nov 2022
- FDA classified
- 19 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Nov 2022 | Recall initiated by company | |
| 19 Dec 2022 | Classified by FDA | +34 days |
| 28 Dec 2022 | Published 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
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
Product as listed by the FDA
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
Which lots are affected?
REF number 420861, Batch 1C03858, exp 01 Mar 2023
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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