30 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
FDA Recall
Terminated
·BD Diagnostic Systems·Product code GSY·October 20, 2004
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·July 19, 2024
Artix MT Thrombectomy Device, REF: 32-102
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·April 8, 2025
EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.
FDA Recall
Terminated
·Oak Tree International Holdings, LLC, Inc.·Product code NBW·May 26, 2009
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code HXK·September 25, 2019
Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090
FDA Recall
Terminated
·Manan Medical Products, Inc.·Product code KXK·May 3, 2005
BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.
FDA Recall
Terminated
·Bard Brachytherapy, Inc.·Product code KXK·April 10, 2018
HealthPax Cranial Electrotherapy Stimulator
FDA Recall
Terminated
·Health Directions, Inc·Product code JXK·July 19, 2007
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
FDA Recall
Terminated
·Neuro-Fitness LLC·Product code JXK·October 29, 2007
Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code HXK·November 8, 2011
Speed Stitch Needle Cassette
FDA Recall
Open, Classified
·ArthroCare Corporation·Product code HXK·August 17, 2020
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
PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.
FDA Recall
Terminated
·Theragenics Corporation·Product code KXK·May 16, 2005
M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
FDA Recall
Terminated
·Source Production & Equipment Inc·Product code KXK·March 3, 2008