PlainRecalls

Convatec Inc.

31 recalls on record · Latest: Apr 17, 2024

Convatec Inc. Recall Insight

Convatec Inc. appears on 31 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.037% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 17, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 31 entries, severity tagging shows 0 critical, 30 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 31 of 31 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (31). The date window on this page runs from Aug 28, 2013 to Apr 17, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 17, 2024

ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/…

FDA Devices Moderate Mar 27, 2024

Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, …

FDA Devices Moderate Mar 13, 2024

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

FDA Devices Moderate Dec 28, 2022

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

FDA Devices Moderate Nov 2, 2022

ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileo…

FDA Devices Moderate Nov 2, 2022

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or…

FDA Devices Moderate Nov 2, 2022

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or il…

FDA Devices Moderate Jun 1, 2022

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

FDA Devices Moderate Oct 6, 2021

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

FDA Devices Moderate Sep 29, 2021

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X…

FDA Devices Moderate Mar 27, 2019

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters ar…

FDA Devices Moderate Mar 27, 2019

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and St…

FDA Devices Moderate Aug 22, 2018

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasiv…

FDA Devices Moderate May 23, 2018

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut…

FDA Devices Moderate Jun 14, 2017

Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

FDA Devices Moderate Jun 14, 2017

Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

FDA Devices Moderate Jun 14, 2017

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Co…

FDA Devices Moderate Jun 14, 2017

Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

FDA Devices Moderate Jun 14, 2017

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

FDA Devices Moderate Jun 14, 2017

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,…

FDA Devices Moderate Jun 14, 2017

Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM

FDA Devices Moderate Jun 14, 2017

Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

FDA Devices Moderate Jun 14, 2017

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve…

FDA Devices Moderate Jun 14, 2017

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 C…

FDA Devices Moderate Mar 9, 2016

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directl…

FDA Devices Moderate Mar 26, 2014

JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lu…

FDA Devices Moderate Mar 26, 2014

SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially con…

FDA Devices Moderate Mar 26, 2014

'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially …

FDA Devices Moderate Mar 26, 2014

SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essen…

FDA Devices Moderate Mar 26, 2014

Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard c…

FDA Devices Low Aug 28, 2013

ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds