Chrysalis Intelligence · Sponsors · Convatec, Inc.

Convatec, Inc.

Greensboro, NC, US · 9 510(k) clearances · 18 recalls

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Total clearances
9
2022-06-22 → 2026-08-05
Last 12 months
2
Product codes
4
Most recent
2026-08-05
Name variants in FDA filings: Convatec Limited / Convatec, Inc. / Convatec
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EZD Catheter, Straight Class II Gastroenterology, Urology 6 2026-08-05
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Class II Gastroenterology, Urology 1 2025-06-06
KNT Tubes, Gastrointestinal (And Accessories) Class II Gastroenterology, Urology 1 2025-03-28
GBM Catheter, Urethral Class II Gastroenterology, Urology 1 2022-06-22
Safety

Recalls (18)

Class I (serious)
0
Risk of injury / death
Total recalls
18
Currently ongoing
17
Most recent
2026-07-06
DateSeverityStatusRecall # ProductCodeReason
2026-07-06 Class II Ongoing Z-2986-2026 Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 4… — Urostomy Pouches may leak from cap during use.
2026-06-08 Class II Ongoing Z-2677-2026 Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R — Surgical dressing manufactured out of specification (greater thickness).
2026-02-16 Class II Ongoing Z-1584-2026 Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm — Drainable large pouch may leak due to manufacturing issue.
2026-02-16 Class II Ongoing Z-1583-2026 Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm — Drainable large pouch may leak due to manufacturing issue.
2026-02-16 Class II Ongoing Z-1582-2026 Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm — Drainable large pouch may leak due to manufacturing issue.
2025-08-29 Class II Ongoing Z-0160-2026 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud… — Wound dressing may have foreign matter on the product.
2024-11-29 Class II Ongoing Z-0903-2025 Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh… — Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too …
2024-02-27 Class II Ongoing Z-1495-2024 ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i… — The product does not meet sterility assurance level.
2024-02-19 Class II Ongoing Z-1350-2024 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4… — Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in …
2024-01-17 Class II Ongoing Z-1276-2024 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. — The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
2022-11-15 Class II Ongoing Z-0723-2023 ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive — ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of…
2022-08-16 Class II Ongoing Z-0130-2023 ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output … — impaired functionality of the release liner
2022-08-16 Class II Ongoing Z-0129-2023 ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output … — impaired functionality of the release liner
2022-08-16 Class II Ongoing Z-0128-2023 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma ou… — impaired functionality of the release liner
2022-08-16 Class II Ongoing Z-0127-2023 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu… — impaired functionality of the release liner
2022-04-22 Class II Terminated Z-1134-2022 SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. — Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
2021-08-20 Class II Ongoing Z-2614-2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) — Primary packaging labeling may be incorrect.
2021-08-09 Class II Ongoing Z-2519-2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Ex… — There is a potential for open seals which can compromise sterility.
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-08-05 K260737 Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). EZD Class II Gastroenterology, Urology
2026-04-01 K252943 GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women EZD Class II Gastroenterology, Urology
2025-07-01 K250699 Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) EZD Class II Gastroenterology, Urology
2025-06-06 K250891 Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C FCM Class II Gastroenterology, Urology
2025-03-28 K243228 Flexi-Seal AIR (with ENFit Connector) KNT Class II Gastroenterology, Urology
2024-01-25 K232665 GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) EZD Class II Gastroenterology, Urology
2023-11-08 K230400 Cure Catheter Closed System; Cure Dextra Closed System EZD Class II Gastroenterology, Urology
2022-11-17 K221593 Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus EZD Class II Gastroenterology, Urology
2022-06-22 K213283 GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter GBM Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence