Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 165 of 548
FDA Devices Moderate Oct 20, 2021
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Philips North America LLC
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
FDA Devices Moderate Oct 20, 2021
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Oct 20, 2021
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
ELEKTA SOLUTIONS AB
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
Thoraguard Chest Tube Kit, 20 Fr
Centese Inc.
FDA Devices Moderate Oct 20, 2021
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems, Inc.
FDA Devices Moderate Oct 20, 2021
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Syn…
Elekta, Inc.
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Oct 20, 2021
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (…
Draeger Medical, Inc.
FDA Devices Moderate Oct 20, 2021
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
K2M, Inc
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
BioMerieux SA
FDA Devices Critical Oct 20, 2021
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Red Medical Supplies
FDA Devices Moderate Oct 20, 2021
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Intuitive Surgical, Inc.
FDA Devices Moderate Oct 20, 2021
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Impl…
Flower Orthopedics Corporation
FDA Devices Critical Oct 20, 2021
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
FDA Devices Critical Oct 20, 2021
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Red Medical Supplies
FDA Devices Critical Oct 20, 2021
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Red Medical Supplies
FDA Devices Moderate Oct 20, 2021
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 m…
W L Gore & Associates, Inc.
FDA Devices Critical Oct 20, 2021
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/c…
National Distribution & Contracting Inc
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
FDA Devices Moderate Oct 20, 2021
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Philips North America LLC
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 20, 2021
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
FDA Devices Moderate Oct 20, 2021
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8…
Draeger Medical, Inc.
FDA Devices Moderate Oct 20, 2021
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant…
Flower Orthopedics Corporation
FDA Devices Critical Oct 20, 2021
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
FDA Devices Moderate Oct 20, 2021
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Uoc Usa Inc
FDA Devices Moderate Oct 13, 2021
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN CO…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital re…
Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Oct 13, 2021
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, R…
ZOLL Circulation, Inc.
FDA Devices Low Oct 13, 2021
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, C…
Sentinel CH SpA
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lum…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
CardioQuip, LLC
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lum…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is desig…
Johnson & Johnson Surgical Vision Inc
FDA Devices Moderate Oct 13, 2021
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital re…
Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Oct 13, 2021
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Beckman Coulter Inc.
FDA Devices Moderate Oct 13, 2021
Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin CO…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN …
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips Ultrasound Inc
FDA Devices Moderate Oct 13, 2021
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. …
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
CardioQuip, LLC
FDA Devices Moderate Oct 13, 2021
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
NOX MEDICAL