Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N recall — FDA Z-2834-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Latest records
Latest recalls — page 977
The newest recall records with useful source details are listed here.
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N recall — FDA Z-2840-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
GE Healthcare CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor recall — FDA Z-2883-2020
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction recall — FDA Z-2891-2020
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 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recall — FDA Z-2901-2020
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
Karl Storz Endoscopy Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction recall — FDA Z-2894-2020
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
Materialise N.V Match Point System The Match Point System is intended to by uses as a recall — FDA Z-2886-2020
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
Class IIFDA: TerminatedMaterialise N.V.
Medical DeviceSep 2, 2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral recall — FDA Z-2876-2020
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: 11302BDX, with Instruction recall — FDA Z-2896-2020
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
Ortho-Clinical Diagnostics VITROS Chemistry Products BuBc Slides - in vitro diagnostic use recall — FDA Z-2874-2020
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)-Sensation 7Fr 40cc IAB Kit P/N recall — FDA Z-2835-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit recall — FDA Z-2844-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only recall — FDA Z-2906-2020
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
The Magstim Company Neurosign V4 Intraoperative Nerve monitor family of devices recall — FDA Z-2884-2020
Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the…
Class IIFDA: TerminatedThe Magstim Company Limited
Medical DeviceSep 2, 2020
Canon Medical System, USA System Model: Ultimax-i, DREX-UI80 (DREX-UI80) recall — FDA Z-2885-2020
During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only recall — FDA Z-2905-2020
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 Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The recall — FDA Z-2887-2020
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.
Medical DeviceSep 2, 2020
Neurovision Medical Products Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recall — FDA Z-2900-2020
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
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
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.
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Recent recall archives
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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