Medical DeviceSep 2, 2020
Klarity Vacuum Bags, Item Nos recall — FDA Z-2881-2020
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Class IIFDA: TerminatedKlarity Medical Products LLC
Monthly breakdown
2020 recalls by month
Select a month to review the recall records reported during that period.
December 2020315 records · 4 categoriesNovember 2020241 records · 4 categoriesOctober 2020416 records · 4 categoriesSeptember 2020371 records · 4 categoriesAugust 2020245 records · 4 categoriesJuly 2020442 records · 4 categoriesJune 2020342 records · 4 categoriesMay 2020315 records · 4 categoriesApril 2020422 records · 4 categoriesMarch 2020368 records · 4 categoriesFebruary 2020551 records · 4 categoriesJanuary 2020224 records · 4 categories
2020 recalls — page 54
Records are ordered by the best available source date.
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N recall — FDA Z-2836-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N recall — FDA Z-2845-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N recall — FDA Z-2832-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Ortho-Clinical Diagnostics VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro recall — FDA Z-2873-2020
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
Siemens Medical Solutions USA Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model recall — FDA Z-2848-2020
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
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
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
About the 2020 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.