Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (ste...
Medical Devices·25 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (ster...
Medical Devices·2,415 affected·Jun 8, 2020
High RiskFDA
Medtronic Navigation, Inc.
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locat...
Medical Devices·2 affected·Jun 5, 2020
CriticalFDA
Verathon, Inc.
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core One...
Medical Devices·437 affected·Jun 5, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Calibrator
Medical Devices·1,872 affected·Jun 5, 2020
High RiskFDA
Richard Wolf Gmbh
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure...
Medical Devices·338 affected·Jun 5, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Medical Devices·37,360 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager, Model Number 24970A
Medical Devices·2,773 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure S DR MRI, Model Number W3DR01
Medical Devices·49,513 affected·Jun 4, 2020
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chro...
Medical Devices·3,000 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·5 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·155 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
Medical Devices·266,252 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure S SR MRI, Model Number W3SR01
Medical Devices·11,953 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
Medical Devices·31,736 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Patient Connector, Model Number 24967
Medical Devices·1,025 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·95 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
Medical Devices·17,750 affected·Jun 4, 2020
High RiskFDA
Longhorn Vaccines And Diagnostic
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intend...
Medical Devices·1,936,050 affected·Jun 3, 2020
High RiskFDA
Baxter Healthcare Corporation
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Medical Devices·60 affected·Jun 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Medical Devices·436 affected·May 27, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available i...
Medical Devices·4,615 affected·May 26, 2020
High RiskFDA
U&i Corp.
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Medical Devices·6 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available a...
Medical Devices·3,899 affected·May 26, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1,...
Medical Devices·12 affected·May 26, 2020
High RiskFDA
Smiths Medical Asd Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Medical Devices·20 affected·May 26, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Medical Devices·529 affected·May 22, 2020
High RiskFDA
Vitalconnect Inc.
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display phys...
Medical Devices·7 affected·May 21, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Medical Devices·130 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Medical Devices·353 affected·May 20, 2020
High RiskFDA
Roi Cps Llc
Isolation Droplet Bundle Kit
Medical Devices·24 affected·May 19, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to ...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Nu...
Medical Devices·89,109 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer trea...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Tedan Surgical Innovations Llc
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervic...
Medical Devices·2,735 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020