Manufacturer

ConvaTec, Inc

54 recalls in our database name ConvaTec, Inc as the manufacturing or recalling firm.

What the numbers show

Total: 54
Critical: 0
Severe: 0
Most recent: 2026-08-26

Of the 54 recalls from ConvaTec, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 54

ModerateFDA (Devices)·Z-0525-2018·2018-02-14
ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products
ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.
Product
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2233-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks. The recall was initiated due to quality concerns, though no specific defect is described in the source.
Product
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2228-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Tubing Detachment Risk
ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.
Product
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2229-2017·2017-06-14
ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing
ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.
Product
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2235-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns
ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.
Product
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2244-2017·2017-06-14
ConvaTec Recalls Adult Non-Rebreather Masks Due to Defect
ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.
Product
Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2243-2017·2017-06-14
ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
Product
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2236-2017·2017-06-14
ConvaTec Recalls Rebreather Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.
Product
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2237-2017·2017-06-14
ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks
ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.
Product
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2234-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Masks Due to Potential Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Masks due to a potential defect in the check valve. The recall covers units distributed in the US and internationally.
Product
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2231-2017·2017-06-14
ConvaTec Recalls Adult High Concentration Non-Rebreather Oxygen Masks
ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.
Product
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2232-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.
Product
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2241-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2240-2017·2017-06-14
ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Valve Defect
ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.
Product
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2239-2017·2017-06-14
ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect
ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.
Product
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2230-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2245-2017·2017-06-14
ConvaTec Recalls Pediatric High Concentration Non-Rebreather Oxygen Tubing
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.
Product
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2238-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns
ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.
Product
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2242-2017·2017-06-14
ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks
ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.
Product
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1044-2016·2016-03-09
ConvaTec Recalls Opti-Mist Nebulizer Masks Due to Reduced Aerosol Output
ConvaTec is recalling Opti-Mist and Opti-Mist Clear nebulizer masks because a component defect reduces or stops aerosol output, potentially preventing patients from receiving medication.
Product
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1785-2014·2014-06-25
Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues
Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.
Product
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1241-2014·2014-03-26
Convatec Latex Foley Catheters Recalled Due to Blocked Lumen
Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
Product
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1239-2014·2014-03-26
Convatec Recalls Latex Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling 31,250 latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
Product
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tu
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1237-2014·2014-03-26
Convatec Recalls Latex Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.
Product
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1240-2014·2014-03-26
Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
Product
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens construc
Category
Medical Device
Distribution
1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ConvaTec

UK medical products and technologies company

Country: United Kingdom
Founded: 1978

Official website

Source: Wikidata (Q5166105), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.