95 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Recall
Open, Classified
·Brainlab AG Olof-Palme-Str. 9 Munich Germany·Product code LLZ·February 10, 2025
X80 RADiant Photoelectric Therapy System
FDA Recall
Open, Classified
·Xstrahl Limited·Product code JAD·April 27, 2022
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code KGX·December 26, 2025
CURAD FIRST AID KIT, SKU 999037
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code LRR·June 23, 2022
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code JET·December 5, 2022
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
FDA Recall
Open, Classified
·Breg Inc·Product code ITJ·September 13, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code KNS·December 18, 2025
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
FDA Recall
Open, Classified
·Medtronic, PLC·Product code CCW·January 28, 2020
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
FDA Recall
Open, Classified
·DERMASENSOR INC·Product code QZS·October 13, 2025
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021