Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Becton Dickinson & Company
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666),...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 008...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 008017410...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 008...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Anjon Holdings
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fi...
Medical Devices·249 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitor...
Medical Devices·9,705 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI ...
Medical Devices·24,545 affected·Jun 18, 2020
High RiskFDA
Chembio Diagnostics, Inc
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection a...
Medical Devices·126 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Mon...
Medical Devices·118 affected·Jun 18, 2020
High RiskFDA
Chembio Diagnostics, Inc
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobuli...
Medical Devices·7,674 affected·Jun 18, 2020
High RiskFDA
Fhc, Inc.
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well...
Medical Devices·6 affected·Jun 17, 2020
High RiskFDA
Resource Optimization & Innovation Llc
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed ...
Medical Devices·66 affected·Jun 17, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-161XPS
Medical Devices·345,244 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset With Female Luer, REF: A120-160XPSN
Medical Devices·50 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-160X2YB
Medical Devices·5,000 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard BodySet, REF: A120-160SAS
Medical Devices·3,250 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-160XSFK
Medical Devices·273,700 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
CMExpress Microbore Sets, REF: A120-161C
Medical Devices·50,122 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
Medical Devices·152,570 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard set with Female Luer, REF: A120-003XSN
Medical Devices·7,200 affected·Jun 16, 2020
High RiskFDA
Synthes Produktions Gmbh
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures ...
Medical Devices·41 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Filter, REF: A120-160XSFE
Medical Devices·16,850 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Medical Devices·6,320 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-161XPSV
Medical Devices·291,386 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-161XYBS
Medical Devices·18,520 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A100-163XSL
Medical Devices·28,600 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
Standard BodySet with Needleless Connectors, REF: A120-125XS
Medical Devices·36,286 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Medical Devices·8,016 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Filter, REF: A100-164XESF
Medical Devices·55,455 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A100-163XE90S
Medical Devices·390,230 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-003XS2YV
Medical Devices·169,856 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Medical Devices·6,016 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-112XSFK
Medical Devices·1,273,892 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-160XYSF
Medical Devices·50 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A100-163XESV
Medical Devices·178,057 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Filter, REF: A100-163XESF
Medical Devices·95,110 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
CMExpress Microbore Set, REF: A120-160C
Medical Devices·13,280 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
CMExpress Microbore Set, REF: A120-160CRV
Medical Devices·402,026 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Medical Devices·198,160 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-160XPS
Medical Devices·479,559 affected·Jun 16, 2020
High RiskFDA
Ethicon, Inc.
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W181...
Medical Devices·99,612 affected·Jun 10, 2020
High RiskFDA
Nuvasive Inc
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative ...
Medical Devices·23 affected·Jun 10, 2020
High RiskFDA
Elekta Instrument Ab
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Medical Devices·51 affected·Jun 10, 2020
High RiskFDA
New Standard Device Inc
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Medical Devices·426 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (ster...
Medical Devices·352 affected·Jun 8, 2020
High RiskFDA
Hocoma Ag
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 Lo...
Medical Devices·494 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (steri...
Medical Devices·5 affected·Jun 8, 2020