ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error
Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is limited to a packaging labeling error (duplicated lot numbers) with no reported injuries.
Plain-English summary
Convatec Inc. is recalling 22,896 units of ConvaTec Flexi-Seal Signal Plus, a prescription-only medical device used to manage fecal incontinence. The recall was initiated after the manufacturer identified a manufacturing irregularity related to the packaging of specific lots.
The issue involves the lot number convention being duplicated on the packaging for certain lots. The affected products are identified by ICC Code 418000, SAP Code 1705108, and Lots 12-FM-01 and 12-FM-02. These units were distributed nationwide in the United States.
Convatec notified customers on June 25, 2013, regarding this irregularity. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
- Manufacturer
- Convatec Inc.
- Hazard
- Affected units
- 22,896
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)
- Flexi-Seal Signal + ICC Code 418000
- SAP Code# 1705108
- Lots 12-FM-01 and 12-FM-02.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 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 423653 may leak
FDA (Devices) · 2026-03-25
- 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
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02