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ConvaTec, Inc

48 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R recall (Z-2677-2026)ConvaTec, Inc2026-07-07
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm recall (Z-1582-2026)ConvaTec, Inc2026-03-19
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm recall (Z-1583-2026)ConvaTec, Inc2026-03-19
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm recall (Z-1584-2026)ConvaTec, Inc2026-03-19
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed recall (Z-0160-2026)ConvaTec, Inc2025-10-16
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece osto recall (Z-0903-2025)ConvaTec, Inc2025-01-10
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. recall (Z-1276-2024)ConvaTec, Inc2024-09-30
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, S recall (Z-1495-2024)ConvaTec, Inc2024-04-08
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 42365 recall (Z-1350-2024)ConvaTec, Inc2024-03-21
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive recall (Z-0723-2023)ConvaTec, Inc2022-12-19
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For recall (Z-0127-2023)ConvaTec, Inc2022-10-24
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For recall (Z-0128-2023)ConvaTec, Inc2022-10-24
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For t recall (Z-0129-2023)ConvaTec, Inc2022-10-24
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For t recall (Z-0130-2023)ConvaTec, Inc2022-10-24
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; recall (Z-2228-2017)ConvaTec, Inc2017-05-24
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM recall (Z-2229-2017)ConvaTec, Inc2017-05-24
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Cod recall (Z-2230-2017)ConvaTec, Inc2017-05-24
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code recall (Z-2231-2017)ConvaTec, Inc2017-05-24
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Che recall (Z-2232-2017)ConvaTec, Inc2017-05-24
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product recall (Z-2233-2017)ConvaTec, Inc2017-05-24
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code recall (Z-2234-2017)ConvaTec, Inc2017-05-24
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., recall (Z-2235-2017)ConvaTec, Inc2017-05-24
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, recall (Z-2236-2017)ConvaTec, Inc2017-05-24
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Chec recall (Z-2237-2017)ConvaTec, Inc2017-05-24
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 310 recall (Z-2238-2017)ConvaTec, Inc2017-05-24
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2 recall (Z-2239-2017)ConvaTec, Inc2017-05-24
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2 recall (Z-2240-2017)ConvaTec, Inc2017-05-24
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Co recall (Z-2241-2017)ConvaTec, Inc2017-05-24
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2. recall (Z-2242-2017)ConvaTec, Inc2017-05-24
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD recall (Z-2243-2017)ConvaTec, Inc2017-05-24
Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code recall (Z-2244-2017)ConvaTec, Inc2017-05-24
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connec recall (Z-2245-2017)ConvaTec, Inc2017-05-24
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquid recall (Z-1044-2016)ConvaTec, Inc2016-03-03
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For u recall (Z-1785-2014)Convatec Inc.2014-06-13
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:L recall (Z-1236-2014)Convatec Inc.2014-03-20
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex recall (Z-1237-2014)Convatec Inc.2014-03-20
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubrico recall (Z-1238-2014)Convatec Inc.2014-03-20
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The s recall (Z-1239-2014)Convatec Inc.2014-03-20
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coa recall (Z-1240-2014)Convatec Inc.2014-03-20
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coate recall (Z-1241-2014)Convatec Inc.2014-03-20
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to mana recall (Z-1990-2013)Convatec Inc.2013-08-20
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence recall (Z-1991-2013)Convatec Inc.2013-08-20
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Req recall (Z-0013-2012)Convatec Inc.2011-10-05
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/ recall (Z-1610-2011)Convatec Inc.2011-03-08
Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical recall (Z-1255-2011)Convatec Inc.2011-02-15
Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with recall (Z-1256-2011)Convatec Inc.2011-02-15
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made recall (Z-0073-2011)Convatec Inc.2010-10-18
Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy recall (Z-2609-2010)Convatec Inc.2010-09-28

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Every clearance here is in the API, with alerts when new ones post.