RegWardenFDA facility compliance records
Recall

Class II — ConvaTec, Inc

Recalling firmConvaTec
Registered facilityView this company's 6 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonConvaTec 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.
ProductConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Quantity5300 devices
DistributionUS Nationwide distribution.
Initiated2022-11-15
Classified2022-12-19
Recall numberZ-0723-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — ConvaTec, Inc (Z-0723-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91081/

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