Data / Medical devices / United States / ConvaTec, Inc.
ConvaTec, Inc.: FDA-registered device maker in Greensboro, NC, United States, 54 510(k) clearances
ConvaTec, Inc. is registered with the FDA (registration 3011987967) in Greensboro, NC, United States. It lists 70 device types. The FDA files 54 510(k) clearances under its listings, the newest dated August 5, 2026. 37 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011987967
- Address
- 7815 National Service Road Suite 600, Greensboro, NC, United States, 27409
- Owner or operator
- ConvaTec (2241599)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 1, 1981
- Registered through
- 2026
- Brand names listed
- 365-E (ADULT), 367-E (PEDIATRIC), ABVISER, ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive, ACTIVE LIFE One-Piece Closed-End Pouch, ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier, ACTIVE LIFE One-Piece Urostomy Pouch Durahesive, AQUACEL Ag and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2026 | K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | EZD | Substantially Equivalent | Convatec | accessdata.fda.gov |
| June 24, 2026 | K253263 | ConvaVAC Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Convatec Limited, Gdc Building | accessdata.fda.gov |
| July 1, 2025 | K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | EZD | Substantially Equivalent | Convatec | accessdata.fda.gov |
| June 6, 2025 | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | FCM | Unknown | Convatec Limited | accessdata.fda.gov |
| March 28, 2025 | K243228 | Flexi-Seal AIR (with ENFit Connector) | KNT | Substantially Equivalent | Convatec | accessdata.fda.gov |
| January 25, 2024 | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | EZD | Substantially Equivalent | Convatec | accessdata.fda.gov |
| November 8, 2023 | K230400 | Cure Catheter Closed System; Cure Dextra Closed System | EZD | Unknown | Convatec, Inc. | accessdata.fda.gov |
| November 17, 2022 | K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | EZD | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| June 22, 2022 | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | GBM | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| April 30, 2019 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| October 19, 2018 | K180205 | AVELLE Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| August 16, 2018 | K181206 | GentleCath Glide Intermittent Urinary Catheter | GBM | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| July 20, 2018 | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | FRO | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| November 21, 2017 | K172924 | GentleCath Intermittent Urinary Catheter | KOD | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| March 7, 2017 | K162906 | Flexi-Seal PROTECT Fecal Management System | KNT | Substantially Equivalent | Convatec | accessdata.fda.gov |
| September 20, 2016 | K161344 | GentleCath Glide Intermittent Catheter | KOD | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| January 21, 2016 | K152926 | AQUACEL Ag Surgical SP Dressing | FRO | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| July 21, 2015 | K150350 | Flexi-Seal Signal Fecal Management System | KNT | Substantially Equivalent | Convatec, Ltd. | accessdata.fda.gov |
| December 23, 2013 | K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED | EZD | Substantially Equivalent | Cure Medical, LLC | accessdata.fda.gov |
| June 6, 2013 | K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE | FRO | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| July 25, 2012 | K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER | FRO | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| April 26, 2012 | K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM | KNT | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| April 20, 2012 | K120872 | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS | FPA | Substantially Equivalent | Unomedical A/S Infusion Devices | accessdata.fda.gov |
| August 1, 2011 | K110653 | CURE CATHETER | EZD | Substantially Equivalent | Cure Medical, LLC | accessdata.fda.gov |
| December 16, 2009 | K091034 | AQUACEL AG SURGICAL | FRO | Substantially Equivalent | Convatec | accessdata.fda.gov |
| September 4, 2009 | K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) | FRO | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons, LLC | accessdata.fda.gov |
| June 11, 2008 | K080881 | CURE CATHETER CLOSED SYSTEM | KOD | Substantially Equivalent | Cure Medical, LLC | accessdata.fda.gov |
| May 2, 2008 | K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING | FRO | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons, LLC | accessdata.fda.gov |
| September 13, 2007 | K072539 | CURE CATHETER | EZD | Substantially Equivalent | Cure Medical, LLC | accessdata.fda.gov |
| April 8, 2004 | K032734 | CONVATEC FECAL MANAGEMENT SYSTEM | KNT | Substantially Equivalent | Convatec, A Bristol-Myers Squibb Co. | accessdata.fda.gov |
| May 9, 2001 | K010420 | RUSCH MMG/O'NEIL CATHETER | FCM | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| September 16, 1998 | K973076 | EUROMEDICAL HAEMATURIA FOLEY CATHETER | EZL | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| March 21, 1997 | K965120 | ALLCLENZ WOUND CLEANSER | KMF | Substantially Equivalent for Some Indications | Dpt Laboratories, Ltd. | accessdata.fda.gov |
| November 21, 1996 | K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| October 30, 1995 | K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | EZL | Substantially Equivalent | Regulatory & Marketing Services, Inc. | accessdata.fda.gov |
| June 29, 1995 | K944007 | EUROPHILIC SLIPPERY COATED FOLEY CATHETER | EZL | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 22, 1995 | K951697 | PEDIATRIC ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| May 22, 1995 | K951696 | ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| March 21, 1995 | K945806 | SILICATH ALL SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| December 27, 1994 | K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | JOH | Substantially Equivalent | Regulatory & Marketing Services, Inc. | accessdata.fda.gov |
| November 30, 1994 | K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | CAH | Substantially Equivalent | Hospitak, Inc. | accessdata.fda.gov |
| February 11, 1992 | K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | CCK | Substantially Equivalent | Hospitak, Inc. | accessdata.fda.gov |
| December 21, 1990 | K896734 | FEEDING TUBE | FPD | Substantially Equivalent | Unoplast A/S | accessdata.fda.gov |
| November 5, 1990 | K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | KOD | Substantially Equivalent | Unoplast A/S | accessdata.fda.gov |
| December 3, 1987 | K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | KOD | Substantially Equivalent | American Pharmaseal Div. Ahsc | accessdata.fda.gov |
| October 26, 1987 | K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | BTM | Substantially Equivalent | Hospitak, Inc. | accessdata.fda.gov |
| August 8, 1984 | K842395 | SUR-FIT NIGHT DRAINAGE CONTAINER SET | KNX | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons | accessdata.fda.gov |
| July 9, 1984 | K841544 | AMER. PHARMASEAL SILICONIZED LATEX | KOD | Substantially Equivalent | American Pharmaseal Div. Ahsc | accessdata.fda.gov |
| August 26, 1983 | K832299 | VISI-FLOW IRRIGATOR | EXD | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons | accessdata.fda.gov |
| June 16, 1981 | K811240 | SUR-FIT LOOP OSTOMY O.R. SET | EXB | Substantially Equivalent | E. R. Squibb & Sons, Inc. | accessdata.fda.gov |
| June 2, 1981 | K811160 | SUR-FIT IRRIGATION SLEEVE | EXD | Substantially Equivalent | E. R. Squibb & Sons, Inc. | accessdata.fda.gov |
| September 7, 1979 | K791536 | DISPOSABLE MEDICATION NEBULIZER | CAF | Substantially Equivalent | Hospitak, Inc. | accessdata.fda.gov |
| February 17, 1977 | K770256 | CATHETERS, SILICONE COATED | KOD | Substantially Equivalent | Pharmaseal Div., Baxter Healthcare Corp. | accessdata.fda.gov |
| August 13, 1976 | K760372 | HUMIDIFIER, DISPOSABLE | BTT | Substantially Equivalent | Hospitek | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 6, 2026 | 99457 | Class II | Ongoing | Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727 | Urostomy Pouches may leak from cap during use. | accessdata.fda.gov |
| June 8, 2026 | 99151 | Class II | Ongoing | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | Surgical dressing manufactured out of specification (greater thickness). | accessdata.fda.gov |
| February 16, 2026 | 98455 | Class II | Ongoing | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm | Drainable large pouch may leak due to manufacturing issue. | accessdata.fda.gov |
| August 29, 2025 | 97445 | Class II | Ongoing | DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction a | Wound dressing may have foreign matter on the product. | accessdata.fda.gov |
| November 29, 2024 | 95955 | Class II | Ongoing | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEE | 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 | accessdata.fda.gov |
| February 27, 2024 | 94148 | Class II | Ongoing | ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit. | The product does not meet sterility assurance level. | accessdata.fda.gov |
| February 19, 2024 | 94121 | Class II | Ongoing | Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423 | 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. | accessdata.fda.gov |
| January 17, 2024 | 93896 | Class II | Ongoing | ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. | accessdata.fda.gov |
| November 15, 2022 | 91081 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 16, 2022 | 90856 | Class II | Ongoing | 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 ileostomy procedure. | impaired functionality of the release liner | accessdata.fda.gov |
| April 22, 2022 | 90041 | Class II | Terminated | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. | accessdata.fda.gov |
| August 20, 2021 | 88557 | Class II | Ongoing | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | Primary packaging labeling may be incorrect. | accessdata.fda.gov |
| August 9, 2021 | 88460 | Class II | Ongoing | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) | There is a potential for open seals which can compromise sterility. | accessdata.fda.gov |
| September 6, 2019 | 83993 | Class II | Terminated | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management | 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. | accessdata.fda.gov |
| January 9, 2019 | 82039 | Class II | Ongoing | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | accessdata.fda.gov |
| July 3, 2018 | 80539 | Class II | Terminated | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspirat | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. | accessdata.fda.gov |
| April 25, 2018 | 79953 | Class II | Terminated | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy sys | 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. | accessdata.fda.gov |
| October 26, 2017 | 78507 | Class II | Terminated | 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. | 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). | accessdata.fda.gov |
| May 10, 2017 | 77282 | Class II | Terminated | Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E | 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 o | accessdata.fda.gov |
| November 11, 2015 | 72823 | Class II | Terminated | 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. | 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. | accessdata.fda.gov |
| April 29, 2014 | 68292 | Class I | Terminated | 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 medicati | 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 | accessdata.fda.gov |
| February 7, 2014 | 67588 | Class II | Terminated | Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which i | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | accessdata.fda.gov |
| June 25, 2013 | 65879 | Class III | Terminated | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. | 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. | accessdata.fda.gov |
| June 22, 2011 | 59952 | Not yet classified | Terminated | Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery. | Post-operative kits 57 mm may contain 70 mm pouches. | accessdata.fda.gov |
| February 1, 2011 | 57936 | Not yet classified | Terminated | Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other p | Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together. | accessdata.fda.gov |
| January 7, 2011 | 57626 | Not yet classified | Terminated | Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. Hospilak Ref. N | Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate. | accessdata.fda.gov |
| September 17, 2010 | 56789 | Not yet classified | Terminated | ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch | Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333. | accessdata.fda.gov |
| July 9, 2010 | 56160 | Not yet classified | Terminated | Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy | Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity. | accessdata.fda.gov |
| March 11, 2010 | 54975 | Not yet classified | Terminated | Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring | In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity. | accessdata.fda.gov |
| January 22, 2010 | 54363 | Not yet classified | Terminated | Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. | Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M. | accessdata.fda.gov |
| July 29, 2009 | 52814 | Not yet classified | Terminated | Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, N | Labeling: The expiration date does not appear on the product label. | accessdata.fda.gov |
| July 13, 2009 | 52680 | Not yet classified | Terminated | ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box. | Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched. | accessdata.fda.gov |
| November 20, 2008 | 50225 | Not yet classified | Terminated | Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 ConvaTec Skillman, NJ Made in USA with im | It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device. | accessdata.fda.gov |
| March 7, 2008 | 47210 | Not yet classified | Terminated | GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558. | Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure." | accessdata.fda.gov |
| February 14, 2008 | 46802 | Not yet classified | Terminated | Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558 | Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct. | accessdata.fda.gov |
| July 31, 2006 | 36268 | Not yet classified | Terminated | ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm | Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label. | accessdata.fda.gov |
| July 13, 2006 | 35927 | Not yet classified | Terminated | Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ. | Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size. | accessdata.fda.gov |
Compare with other makers
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Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.