Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 205 of 548
FDA Devices Moderate Sep 2, 2020
VITROS XT7600 Integrated System, Product code 6844461
Ortho Clinical Diagnostics
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acu…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-0…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, usin…
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring a…
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…
Karl Storz Endoscopy
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring …
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
VITROS XT3400 Chemistry System, Product code 6844458
Ortho Clinical Diagnostics
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visual…
Karl Storz Endoscopy
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: A…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and trea…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Sep 2, 2020
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
89 NORTH
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Prod…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Becton Dickinson & Company
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: A…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and v…
Karl Storz Endoscopy
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Globus Medical, Inc.
FDA Devices Low Sep 2, 2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepi…
OraSure Technologies, Inc.
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Co…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobil…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 2, 2020
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and …
Ortho-Clinical Diagnostics
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 06…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: A…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-05…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medica…
Klarity Medical Products LLC
FDA Devices Moderate Sep 2, 2020
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Conformis, Inc.
FDA Devices Moderate Sep 2, 2020
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: …
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging o…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 2, 2020
Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring a…
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Globus Medical, Inc.
FDA Devices Moderate Aug 26, 2020
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Olympus Corporation of the Americas
FDA Devices Moderate Aug 26, 2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Aug 26, 2020
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion …
CareFusion 303, Inc.
FDA Devices Moderate Aug 26, 2020
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device …
Precision Valve & Automation,Inc
FDA Devices Moderate Aug 26, 2020
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (…
Philips North America, LLC
FDA Devices Moderate Aug 26, 2020
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place,…
Smith & Nephew Orthopaedics AG
FDA Devices Moderate Aug 26, 2020
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Moni…
Philips North America, LLC