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.
July 15, 2026Medical DevicesFDA
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Hazard: Surgical dressing manufactured out of specification (greater thickness).
March 25, 2026Medical DevicesFDA
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Hazard: Drainable large pouch may leak due to manufacturing issue.
March 25, 2026Medical DevicesFDA
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Hazard: Drainable large pouch may leak due to manufacturing issue.
March 25, 2026Medical DevicesFDA
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Hazard: Drainable large pouch may leak due to manufacturing issue.
October 22, 2025Medical DevicesFDA
ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud
Hazard: Wound dressing may have foreign matter on the product.
January 22, 2025Medical DevicesFDA
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh
Hazard: 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
April 17, 2024Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i
Hazard: The product does not meet sterility assurance level.
March 27, 2024Medical DevicesFDA
ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4
Hazard: 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.
March 13, 2024Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Hazard: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
December 28, 2022Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Hazard: 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.
November 2, 2022Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output
Hazard: impaired functionality of the release liner
November 2, 2022Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output
Hazard: impaired functionality of the release liner
November 2, 2022Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma ou
Hazard: impaired functionality of the release liner
November 2, 2022Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu
Hazard: impaired functionality of the release liner
June 1, 2022Medical DevicesFDA
ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Hazard: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
October 6, 2021Medical DevicesFDA
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Hazard: Primary packaging labeling may be incorrect.
September 29, 2021Medical DevicesFDA
ConvaTec, Inc recalls DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Ex
Hazard: There is a potential for open seals which can compromise sterility.
November 6, 2019Medical DevicesFDA
ConvaTec, Inc recalls Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2
Hazard: ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
March 27, 2019Medical DevicesFDA
ConvaTec, Inc recalls FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surg
Hazard: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
March 27, 2019Medical DevicesFDA
ConvaTec, Inc recalls Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product
Hazard: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
March 27, 2019Medical DevicesFDA
ConvaTec, Inc recalls Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Pr
Hazard: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
March 27, 2019Medical DevicesFDA
ConvaTec, Inc recalls Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices
Hazard: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
August 22, 2018Medical DevicesFDA
ConvaTec, Inc recalls AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbV
Hazard: Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
May 23, 2018Medical DevicesFDA
ConvaTec, Inc recalls Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive wit
Hazard: It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
February 14, 2018Medical DevicesFDA
ConvaTec, Inc recalls SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intend
Hazard: 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).
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side V
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All
Hazard: FDA Class II
June 14, 2017Medical DevicesFDA
ConvaTec, Inc recalls Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Hazard: FDA Class II