ConvaTec Recalls

39 recalls on record in the United States

medical: 39
medical Class II
2018-02-14

ConvaTec, Inc recalls SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydroco

A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreather Oxygen Mask, Adult High Concentration with 2.

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin), Adult Med Concentratio

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Mask, Elongated (Under the Chin) Pediatric, High Conc

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side V

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-R

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Mask, Standard (Under the Lip) Infant, High Concentra

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Va

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tu

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.

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Mask, Elongated (Under the Chin) Pediatric, High Conc

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, P

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medical Class II
2017-06-14

ConvaTec, Inc recalls Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen T

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medical Class II
2017-06-14

ConvaTec, Inc recalls Rebreathing Mask, Reservoir bag, with Tubing, Product Code 1

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product C

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medical Class II
2017-06-14

ConvaTec, Inc recalls Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Cod

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medical Class II
2017-06-14

ConvaTec, Inc recalls Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-

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medical Class II
2017-06-14

ConvaTec, Inc recalls Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side V

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medical Class II
2025-10-22

ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control g

Wound dressing may have foreign matter on the product.

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medical Class II
2025-01-22

ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem syne

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 big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding

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medical Class II
2024-04-17

ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 40

The product does not meet sterility assurance level.

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medical Class II
2024-03-27

ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product co

Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.

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medical Class II
2024-03-13

ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

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medical Class II
2022-12-28

ConvaTec, Inc recalls 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 brown spots present on several dressings.

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medical Class II
2022-11-02

ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 i

impaired functionality of the release liner

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medical Class II
2022-11-02

ConvaTec, Inc recalls ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4

impaired functionality of the release liner

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medical Class II
2022-11-02

ConvaTec, Inc recalls ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2

impaired functionality of the release liner

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medical Class II
2022-11-02

ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 i

impaired functionality of the release liner

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medical Class II
2022-06-01

ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each m

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

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Showing 30 of 39 recalls. See all →