ConvaTec Recalls
53 recalls on record · August 28, 2013 to July 15, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Pro
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Prod
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM,
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Hazard: Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
March 9, 2016Medical DevicesFDA
ConvaTec, Inc recalls Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gass
Hazard: The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
June 25, 2014Medical DevicesFDA
Convatec Inc. recalls Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal inco
Hazard: Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The stan
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The s
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentia
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheter
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
March 26, 2014Medical DevicesFDA
Convatec Inc. recalls Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated F
Hazard: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
August 28, 2013Medical DevicesFDA
Convatec Inc. recalls ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of
Hazard: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
August 28, 2013Medical DevicesFDA
Convatec Inc. recalls ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence thro
Hazard: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.