64 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 16, 2026
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
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
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code FON·February 16, 2026
BostonSight SCLERAL Lens
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
BostonSight PROSE Lens.
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JGS·November 18, 2021
CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FCN·May 25, 2022
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FBN·September 25, 2023
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FBN·December 18, 2024
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FCN·December 4, 2023
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA Recall
Open, Classified
·TANGENT ENDOSCOPY, LLC·Product code FBN·March 23, 2026
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code GWQ·December 21, 2020
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA Recall
Open, Classified
·W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria·Product code KMW·January 16, 2024
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IZI·March 15, 2019
Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IZI·March 15, 2019
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IZI·March 15, 2019
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code HXK·May 18, 2023
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
FDA Recall
Open, Classified
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025