Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Medical Devices·15 affected·Jun 6, 2019
CriticalFDA
Qiagen Sciences Llc
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 a...
Medical Devices·1,240 affected·Jun 5, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomograph...
Medical Devices·69 affected·Jun 4, 2019
High RiskFDA
Zimmer Biomet, Inc.
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper i...
Medical Devices·8,478 affected·Jun 4, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomograph...
Medical Devices·69 affected·Jun 4, 2019
RecallFDA
Inlightened Partners Llc
inLight Medical LED Pads used with Polychromatic light technology system
Medical Devices·926 affected·Jun 4, 2019
High RiskFDA
Zimmer Biomet, Inc.
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigati...
Medical Devices·8,478 affected·Jun 4, 2019
High RiskFDA
Baxter Healthcare Corporation
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acu...
Medical Devices·65,403 affected·May 31, 2019
High RiskFDA
Ortho Development Corporation
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Medical Devices·27 affected·May 30, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss...
Medical Devices·43 affected·May 30, 2019
CriticalFDA
Galemed Corporation
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Medical Devices·12,000 affected·May 30, 2019
High RiskFDA
Clinical Innovations, Llc
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Man...
Medical Devices·280 affected·May 30, 2019
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Pr...
Medical Devices·360 affected·May 29, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste...
Medical Devices·9 affected·May 28, 2019
High RiskFDA
Gn Otometrics
The ICS CHARTR EP 200
Medical Devices·3,071 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sy...
Medical Devices·24 affected·May 28, 2019
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Medical Devices·1,789 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sys...
Medical Devices·30 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sy...
Medical Devices·53 affected·May 28, 2019
RecallFDA
Abbott Laboratories
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for...
Medical Devices·5,483 affected·May 24, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5...
Medical Devices·55,312 affected·May 24, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Produ...
Medical Devices·1,101,073 affected·May 24, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) H...
Medical Devices·3,238,600 affected·May 24, 2019
CriticalFDA
Teleflex Medical
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Medical Devices·77,136 affected·May 24, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Medical Devices·3,483 affected·May 24, 2019
High RiskFDA
Leventon S. A. U.
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Medical Devices·1,700 affected·May 23, 2019
High RiskFDA
Anewmed Corporation
Various products which were contract sterilized.
Medical Devices·1,749 affected·May 23, 2019
High RiskFDA
Obalon Therapeutics Inc
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended...
Medical Devices·45 affected·May 23, 2019
High RiskFDA
Ge Healthcare, Llc
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 20...
Medical Devices·620 affected·May 22, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-D...
Medical Devices·4 affected·May 20, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfec...
Medical Devices·40 affected·May 20, 2019
High RiskFDA
Covidien Llc
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal V...
Medical Devices·292 affected·May 17, 2019
High RiskFDA
Codman & Shurtleff Inc
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Medical Devices·28 affected·May 16, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthc...
Medical Devices·145 affected·May 16, 2019
High RiskFDA
Ge Healthcare, Llc
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in t...
Medical Devices·82 affected·May 16, 2019
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Medical Devices·308 affected·May 15, 2019
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Medical Devices·1,059 affected·May 15, 2019
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Medical Devices·228 affected·May 15, 2019
CriticalFDA
Edwards Lifesciences, Llc
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-ao...
Medical Devices·6,552 affected·May 14, 2019