ConvaTec CarboFlex Wound Dressing Recalled for Failed Sterility Standards
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where injury has not yet been reported. While the product fails sterility assurance standards, no illnesses, injuries, or hospitalizations have been reported.
Plain-English summary
ConvaTec, Inc. is recalling 63 market units of CarboFlex sterile odor control wound dressings (Order No. 403204, 15cm x 20cm) because the product does not meet sterility assurance level requirements.
The recalled lot numbers are 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343. The product was distributed in California, Missouri, New Mexico, Pennsylvania, Texas, and Washington.
This is a Class II FDA recall.
The recalled product
- Product
- ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 63
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 (5)
- Order #403204 - Lot numbers 3J00675
- 3J02320
- 3J02332
- 3L04811
- and 4A00343.
Distribution
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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighConvaTec DuoDERM wound dressings recalled for potential sterility compromise
FDA (Devices) · 2021-09-29
- ModerateAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects
FDA (Devices) · 2019-10-30
- ModerateDuoDERM Control Gel Formula Border Dressings recalled for incorrect packaging labeling
FDA (Devices) · 2021-10-06
- HighAndover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
FDA (Devices) · 2019-10-30