Convatec Inc.

FDA Regulatory Profile

Summary

Total Recalls
49 (1 Class I)
510(k) Clearances
18
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0160-2026Class IIDuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use onAugust 29, 2025
Z-0903-2025Class IIEsteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system November 29, 2024
Z-1495-2024Class IIConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. PFebruary 27, 2024
Z-1350-2024Class IIConvatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423February 19, 2024
Z-1276-2024Class IIConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, SteJanuary 17, 2024
Z-0723-2023Class IIConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesiveNovember 15, 2022
Z-0128-2023Class IIConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the maAugust 16, 2022
Z-0127-2023Class IIConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the managAugust 16, 2022
Z-0129-2023Class IIConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the managemAugust 16, 2022
Z-0130-2023Class IIConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the managemAugust 16, 2022
Z-1134-2022Class IISUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafersApril 22, 2022
Z-2614-2021Class IIDuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)August 20, 2021
Z-2519-2021Class IIDuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICCAugust 9, 2021
Z-0233-2020Class IIConvex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive September 6, 2019
Z-1037-2019Class IINelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and January 9, 2019
Z-1038-2019Class IIFilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designedJanuary 9, 2019
Z-1036-2019Class IIFeeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and January 9, 2019
Z-1035-2019Class IIForceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterileJanuary 9, 2019
Z-2744-2018Class IIAbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, bJuly 3, 2018
Z-1890-2018Class IIConvatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem SynApril 25, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 CatheteJuly 1, 2025
K243228Flexi-Seal AIR (with ENFit Connector)March 28, 2025
K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)January 25, 2024
K230400Cure Catheter Closed System; Cure Dextra Closed SystemNovember 8, 2023
K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusNovember 17, 2022
K162906Flexi-Seal PROTECT Fecal Management SystemMarch 7, 2017
K150350Flexi-Seal Signal Fecal Management SystemJuly 21, 2015
K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETERAugust 1, 2014
K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEJune 6, 2013
K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERJuly 25, 2012
K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMApril 26, 2012
K111365VITALA CONTINENCE CONTROL DEVICEAugust 19, 2011
K102536VITALA CONTINENCE CONTROL DEVICEDecember 1, 2010
K083785VITALA CONTINENCE CONTROL DEVICEApril 2, 2010
K091034AQUACEL AG SURGICALDecember 16, 2009
K071763AMADEUS ADAPTIVE COMPRESSION THERAPYMarch 7, 2008
K973688DUODERM CONTROL GEL FORMULA BORDER DRESSINGDecember 23, 1997
K973689DUODERM HYDROACTIVE DRESSINGDecember 23, 1997