20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 19, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
FDA Recall
Open, Classified
·T.G. Eakin Limited·Product code EXE·August 8, 2024
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FPD·January 9, 2019
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 debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code HTD·January 9, 2019
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 16, 2026
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EZQ·August 16, 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 ileostomy procedure.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EZQ·August 16, 2022
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·January 17, 2024
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 16, 2026
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code JOL·January 9, 2019
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.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EZQ·August 16, 2022
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 and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code NAD·August 29, 2025
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code KOD·January 9, 2019
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.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code NAC·February 27, 2024
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; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EXE·November 29, 2024
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code NAD·August 9, 2021
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FRO·November 15, 2022
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code NAD·August 20, 2021
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 ileostomy procedure.
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EZQ·August 16, 2022
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 16, 2026