Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N recall — FDA Z-2841-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Latest records
Latest recalls — page 978
The newest recall records with useful source details are listed here.
Medical DeviceSep 2, 2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral recall — FDA Z-2877-2020
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Class IIIFDA: TerminatedOraSure Technologies, Inc.
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction recall — FDA Z-2897-2020
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N recall — FDA Z-2847-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Becton Dickinson & Company BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units recall — FDA Z-2889-2020
Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or…
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N recall — FDA Z-2831-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
89 NORTH LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR recall — FDA Z-2820-2020
The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; specifically, the potential for the LDI to enter a service mode intended for use…
Class IIFDA: Terminated89 NORTH
Medical DeviceSep 2, 2020
RAYSEARCH LABORATORIES AB RayCare, device is stand-alone software - Product Usage: used to recall — FDA Z-2899-2020
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N recall — FDA Z-2846-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction recall — FDA Z-2893-2020
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N recall — FDA Z-2838-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Ortho Clinical Diagnostics VITROS XT3400 Chemistry System, Product code 6844458 recall — FDA Z-2878-2020
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Class IIFDA: TerminatedOrtho Clinical Diagnostics
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only recall — FDA Z-2904-2020
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Class IIFDA: TerminatedNeurovision Medical Products Inc.
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N recall — FDA Z-2837-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction recall — FDA Z-2890-2020
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only recall — FDA Z-2903-2020
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Class IIFDA: TerminatedNeurovision Medical Products Inc.
Medical DeviceSep 2, 2020
Siemens Medical Solutions USA E.cam or Symbia systems that use foresight detectors - Product recall — FDA Z-2898-2020
E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01 recall — FDA Z-2833-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit recall — FDA Z-2843-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Ortho Clinical Diagnostics VITROS XT7600 Integrated System, Product code 6844461 recall — FDA Z-2879-2020
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Class IIFDA: TerminatedOrtho Clinical Diagnostics
Medical DeviceSep 2, 2020
Biosense Webster (israel) CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module recall — FDA Z-2880-2020
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare…
Class IIFDA: TerminatedBiosense Webster (israel), Ltd.
Medical DeviceSep 2, 2020
Ortho-Clinical Diagnostics VITROS XT Chemistry Products TBIL-ALKP Slides recall — FDA Z-2875-2020
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product recall — FDA Z-2842-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Siemens Medical Solutions USA Cios Spin, Image-Intensified Fluoroscopic X-Ray System The recall — FDA Z-2888-2020
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026179 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories