ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction
ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with device malfunction and no reported hospitalizations or injuries. The functional defect affects proper device operation but does not present a direct safety hazard with known harm.
Plain-English summary
ConvaTec, Inc. is recalling 3,209 units of the Active Life One-Piece Drainable Pouch (REF 400598, UDI/DI 768455102891) distributed nationwide. This one-piece pouch is designed for patients who have undergone colostomy or ileostomy procedures to manage stoma output.
The affected units have impaired functionality of the release liner, which may impact proper use of the pouch. The recall includes batch numbers 2A03487 and 2B00300.
Patients currently using this product should stop using it and contact ConvaTec, Inc. for a replacement or alternative solution. Contact the manufacturer with your batch number to confirm whether your product is affected and to obtain further assistance.
The recalled product
- Product
- ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
- Manufacturer
- ConvaTec, Inc
- Hazard
- Affected units
- 3,209
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI: 768455102891
- Batch numbers: 2A03487
- 2B00300
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · ConvaTec, Inc
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- HighConvaTec EsteemBody drainable pouch REF 423657 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423653 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423643 may leak
FDA (Devices) · 2026-03-25
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighConvatec EsteemBody Drainable Pouches Recalled for Filter Weld Defect
FDA (Devices) · 2024-03-27
- HighConvaTec EsteemBody drainable pouch REF 423657 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423643 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423653 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- HighConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach
FDA (Devices) · 2019-03-27