Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 183 of 548
FDA Devices Moderate Apr 28, 2021
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Smiths Medical ASD Inc.
FDA Devices Critical Apr 28, 2021
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Pacific Medical Group Inc.
FDA Devices Moderate Apr 28, 2021
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular de…
BIOTRONIK Inc
FDA Devices Critical Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 11…
Heartware, Inc.
CPSC Moderate Apr 22, 2021
Kawasaki USA Recalls All-Terrain Vehicles Due to Fire Hazard (Recall Alert)
Kawasaki Motors Manufacturing Corp. U.S.A., of Lincoln, Neb.
CPSC Moderate Apr 22, 2021
Kawasaki USA Recalls Recreational Off-Highway Utility Vehicles Due to Fire Hazard (Recall Alert)
Kawasaki Motors Manufacturing Corp. U.S.A., of Lincoln, Neb.
FDA Drug Moderate Apr 21, 2021
foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Indu…
Spartan Chemical Co Inc
FDA Drug Moderate Apr 21, 2021
Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industri…
Spartan Chemical Co Inc
FDA Drug Critical Apr 21, 2021
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and In…
Spartan Chemical Co Inc
FDA Drug Moderate Apr 21, 2021
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institution…
Spartan Chemical Co Inc
FDA Devices Moderate Apr 21, 2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Roche Molecular Systems, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applicati…
Covidien Llc
FDA Devices Moderate Apr 21, 2021
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Sunstar Americas, Inc.
FDA Devices Moderate Apr 21, 2021
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with …
Boston Scientific Corporation
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: …
Roche Molecular Systems, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Covidien, LP
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens contai…
Medline Industries Inc
FDA Devices Moderate Apr 21, 2021
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Krishe Inc
FDA Devices Moderate Apr 21, 2021
VIDAS¿ CMV IgM 30 Tests
Biomerieux Inc
FDA Devices Moderate Apr 21, 2021
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative …
Remel Inc
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: in…
Vectornate USA Inc
FDA Devices Moderate Apr 21, 2021
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number…
K2M, Inc
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Krishe Inc
FDA Devices Moderate Apr 21, 2021
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Apr 21, 2021
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Apr 21, 2021
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 17…
Covidien
FDA Devices Moderate Apr 21, 2021
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
Krishe Inc
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 21, 2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Covidien, LP
FDA Devices Moderate Apr 21, 2021
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
HUBO INTERNATIONAL INC
FDA Devices Low Apr 21, 2021
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The …
OriGen Biomedical, Inc.
FDA Devices Moderate Apr 21, 2021
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with bo…
Stryker Corporation
FDA Devices Moderate Apr 14, 2021
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Sharp Medical Products
FDA Devices Moderate Apr 14, 2021
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Tenderneeds Fertility LLC
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403…
Heartware, Inc.
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-40 plus Instrument
Beckman Coulter Inc.
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-40 plus Reconditioned Instrument
Beckman Coulter Inc.
FDA Devices Moderate Apr 14, 2021
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Tenderneeds Fertility LLC
FDA Devices Moderate Apr 14, 2021
Regard, Item Number 830067009, custom cardiovascular procedure kit
ROi CPS LLC