Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 154 of 548
FDA Devices Moderate Apr 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Graphic Controls Acquisition Corporation
FDA Devices Moderate Apr 20, 2022
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Stanbio Laboratory, LP
FDA Devices Low Apr 20, 2022
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Volcano Corp
FDA Devices Low Apr 20, 2022
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part…
Volcano Corp
CPSC Moderate Apr 14, 2022
Telebrands Recalls Hempvana Pain Relief Products with Lidocaine Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
Telebrands Corp., of Fairfield, N.J.
FDA Devices Moderate Apr 13, 2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Maquet Cardiovascular, LLC
FDA Devices Moderate Apr 13, 2022
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano Corporation
FDA Devices Moderate Apr 13, 2022
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Moderate Apr 13, 2022
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Shimadzu Medical Systems
FDA Devices Moderate Apr 13, 2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
SA3, LLC
FDA Devices Moderate Apr 13, 2022
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Apr 13, 2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin …
DeRoyal Industries Inc
FDA Devices Moderate Apr 13, 2022
Alinity m HBV AMP Kit (US and CE)
Abbott Molecular, Inc.
FDA Devices Moderate Apr 13, 2022
SIGNA Excite 3T. Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Moderate Apr 13, 2022
First SIGN SARS-CoV-2 Antigen Test
WHPM Inc.
FDA Devices Moderate Apr 13, 2022
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Moderate Apr 13, 2022
Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC
FDA Devices Moderate Apr 13, 2022
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 523…
Brius Technologies Inc.
FDA Devices Moderate Apr 13, 2022
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Hologic, Inc
FDA Devices Moderate Apr 13, 2022
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Shimadzu Medical Systems
FDA Devices Moderate Apr 13, 2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 84164…
Draeger Medical, Inc.
FDA Devices Moderate Apr 13, 2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of th…
DeRoyal Industries Inc
FDA Devices Moderate Apr 13, 2022
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
FDA Devices Moderate Apr 13, 2022
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Philips North America LLC
FDA Devices Moderate Apr 13, 2022
Amplatzer Steerable Delivery Sheath
Abbott
FDA Devices Moderate Apr 13, 2022
Surgicare Neuro Pack - Neurological Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Low Apr 13, 2022
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IG…
Cook Medical Incorporated
FDA Devices Moderate Apr 13, 2022
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Ventana Medical Systems Inc
FDA Devices Moderate Apr 13, 2022
Anterior Hip Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Apr 13, 2022
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only…
Philips North America LLC
FDA Devices Moderate Apr 13, 2022
Total Knee Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Apr 13, 2022
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Low Apr 13, 2022
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI…
Cook Medical Incorporated
FDA Devices Moderate Apr 13, 2022
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 7220…
Philips North America Llc
FDA Devices Moderate Apr 13, 2022
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) …
Draeger Medical, Inc.
FDA Devices Moderate Apr 6, 2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210…
Meridian Bioscience Inc
FDA Devices Moderate Apr 6, 2022
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Avanos Medical, Inc.
FDA Devices Moderate Apr 6, 2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Diagnos Inc
FDA Devices Moderate Apr 6, 2022
Hanger-Bar 2P 45cm
Human Care USA, Inc.
FDA Devices Moderate Apr 6, 2022
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Edwards Lifesciences, LLC
FDA Devices Moderate Apr 6, 2022
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Avanos Medical, Inc.
FDA Devices Moderate Apr 6, 2022
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Howmedica Osteonics Corp.
FDA Devices Moderate Apr 6, 2022
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Edwards Lifesciences, LLC
FDA Devices Moderate Apr 6, 2022
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-…
InfuTronix LLC
FDA Devices Moderate Apr 6, 2022
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche Molecular Systems, Inc.
FDA Devices Low Apr 6, 2022
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
ROi CPS LLC
FDA Devices Moderate Apr 6, 2022
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Ansell Healthcare Products LLC
FDA Devices Moderate Apr 6, 2022
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive C…
Microbiologics Inc
FDA Devices Moderate Apr 6, 2022
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Baxter Healthcare Corporation
FDA Devices Moderate Apr 6, 2022
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Avanos Medical, Inc.