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All product recalls associated with ConvaTec, Inc.
Total Recalls
21
Past Year
1
Class I (Serious)
0
Most Recent
Aug 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Wound dressing may have foreign matter on the product.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
The product does not meet sterility assurance level.
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
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.
impaired functionality of the release liner
impaired functionality of the release liner
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Primary packaging labeling may be incorrect.
There is a potential for open seals which can compromise sterility.
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
Labeling: The expiration date does not appear on the product label.
Labeling: The expiration date does not appear on the product label.
Labeling: The expiration date does not appear on the product label.
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."
Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.