Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Corentec Co., Ltd
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Medical Devices·5 affected·Feb 27, 2017
High RiskFDA
Welch Allyn Inc
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 ...
Medical Devices·981 affected·Feb 27, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q and Q.Zen fluoroscopic x-ray system
Medical Devices·2,158 affected·Feb 27, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging ac...
Medical Devices·90 affected·Feb 24, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging ...
Medical Devices·0 affected·Feb 24, 2017
RecallFDA
Philips Medical Systems (cleveland) Inc
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging ...
Medical Devices·27 affected·Feb 24, 2017
High RiskFDA
Carefusion 2200 Inc
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Medical Devices·790 affected·Feb 23, 2017
High RiskFDA
Carefusion 2200 Inc
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
Medical Devices·1,200 affected·Feb 23, 2017
High RiskFDA
Ziehm Imaging Inc
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Medical Devices·2 affected·Feb 23, 2017
High RiskFDA
Streck
Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 21...
Medical Devices·128,692 affected·Feb 23, 2017
High RiskFDA
Carefusion 2200 Inc
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
Medical Devices·14,200 affected·Feb 23, 2017
High RiskFDA
Carefusion 2200 Inc
ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
Medical Devices·13,010 affected·Feb 23, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q, Interventional Fluroscopic x-ray system
Medical Devices·264 affected·Feb 22, 2017
High RiskFDA
Microaire Surgical Instruments, Llc
MicroAire K-Wires
Medical Devices·362 affected·Feb 21, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) ...
Medical Devices·72 affected·Feb 20, 2017
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to ...
Medical Devices·3,794 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained ...
Medical Devices·9 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) inten...
Medical Devices·13 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health...
Medical Devices·18 affected·Feb 20, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Medical Devices·30,700 affected·Feb 20, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b)...
Medical Devices·0 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately tr...
Medical Devices·4 affected·Feb 20, 2017
High RiskFDA
Crossroads Extremity Systems Llc
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Medical Devices·20 affected·Feb 16, 2017
High RiskFDA
Focus Diagnostics Inc
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella p...
Medical Devices·1,400 affected·Feb 15, 2017
High RiskFDA
Intromedic Co., Ltd.
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the sm...
Medical Devices·82 affected·Feb 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (C...
Medical Devices·3,440 affected·Feb 15, 2017
High RiskFDA
Zimmer Biomet, Inc.
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Medical Devices·3,232 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Avant-garde
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Abbott Vascular
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Medical Devices·170,008 affected·Feb 10, 2017
High RiskFDA
Remel Inc
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Medical Devices·4,033 affected·Feb 9, 2017
High RiskFDA
Encore Medical, Lp
Turon Impaction Fixture
Medical Devices·297 affected·Feb 9, 2017
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Medical Devices·142 affected·Feb 9, 2017
High RiskFDA
Cardiovascular Systems Inc
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: ...
Medical Devices·595 affected·Feb 9, 2017
RecallFDA
Tosoh Bioscience, Inc.
AIA-PACK TPOAb CONTROL SET
Medical Devices·15 affected·Feb 8, 2017
High RiskFDA
Medtronic
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Medical Devices·1,096 affected·Feb 8, 2017
High RiskFDA
Corpak Medsystems, Inc.
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications in...
Medical Devices·8 affected·Feb 3, 2017
High RiskFDA
Corpak Medsystems, Inc.
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of...
Medical Devices·2 affected·Feb 3, 2017
High RiskFDA
Corpak Medsystems, Inc.
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enter...
Medical Devices·2 affected·Feb 3, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Medical Devices·2,646 affected·Feb 2, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
Medical Devices·3,462 affected·Feb 2, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
Medical Devices·8,748 affected·Feb 2, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
Medical Devices·4,500 affected·Feb 2, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
Medical Devices·1,410 affected·Feb 2, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
Medical Devices·2,496 affected·Feb 2, 2017
High RiskFDA
Cook Inc.
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Cross...
Medical Devices·1,875 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Medical Devices·1,589 affected·Feb 1, 2017
High RiskFDA
Toshiba American Medical Systems Inc
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Medical Devices·70 affected·Feb 1, 2017