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Convatec Inc.

FDA Regulatory Profile

Convatec Inc. appears in FDA public data with 54 recalls — including 1 Class I (most serious) —, 19 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2986-2026, Class II) was initiated on Jul 6, 2026. Its most recent 510(k) clearance was granted on Aug 5, 2026.

Summary

Total Recalls
54 (1 Class I)
510(k) Clearances
19
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2986-2026Class IIEsteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 42370Jul 6, 2026
Z-2677-2026Class IIAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RJun 8, 2026
Z-1582-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mmFeb 16, 2026
Z-1584-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423657 10-35mmFeb 16, 2026
Z-1583-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423653 10-35mmFeb 16, 2026
Z-0160-2026Class IIDuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use onAug 29, 2025
Z-0903-2025Class IIEsteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system Nov 29, 2024
Z-1495-2024Class IIConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. PFeb 27, 2024
Z-1350-2024Class IIConvatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423Feb 19, 2024
Z-1276-2024Class IIConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, SteJan 17, 2024
Z-0723-2023Class IIConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesiveNov 15, 2022
Z-0129-2023Class IIConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the managemAug 16, 2022
Z-0127-2023Class IIConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the managAug 16, 2022
Z-0130-2023Class IIConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the managemAug 16, 2022
Z-0128-2023Class IIConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the maAug 16, 2022
Z-1134-2022Class IISUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafersApr 22, 2022
Z-2614-2021Class IIDuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)Aug 20, 2021
Z-2519-2021Class IIDuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICCAug 9, 2021
Z-0233-2020Class IIConvex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Sep 6, 2019
Z-1035-2019Class IIForceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterileJan 9, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Aug 5, 2026
K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 CatheteJul 1, 2025
K243228Flexi-Seal AIR (with ENFit Connector)Mar 28, 2025
K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)Jan 25, 2024
K230400Cure Catheter Closed System; Cure Dextra Closed SystemNov 8, 2023
K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusNov 17, 2022
K162906Flexi-Seal PROTECT Fecal Management SystemMar 7, 2017
K150350Flexi-Seal Signal Fecal Management SystemJul 21, 2015
K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETERAug 1, 2014
K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEJun 6, 2013
K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERJul 25, 2012
K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMApr 26, 2012
K111365VITALA CONTINENCE CONTROL DEVICEAug 19, 2011
K102536VITALA CONTINENCE CONTROL DEVICEDec 1, 2010
K083785VITALA CONTINENCE CONTROL DEVICEApr 2, 2010
K091034AQUACEL AG SURGICALDec 16, 2009
K071763AMADEUS ADAPTIVE COMPRESSION THERAPYMar 7, 2008
K973688DUODERM CONTROL GEL FORMULA BORDER DRESSINGDec 23, 1997
K973689DUODERM HYDROACTIVE DRESSINGDec 23, 1997

FDA data resources