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
25,676medical device recall records
2,265FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 577
25,676 detailed records are currently available in this category.
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
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 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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only recall — FDA Z-2908-2020
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 DeviceAug 26, 2020
Olympus Corporation of the Americas Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial recall — FDA Z-2814-2020
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image…
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceAug 26, 2020
Shanghai United Imaging Healthcare Co Positron Emission Tomography and Computed Tomography recall — FDA Z-2819-2020
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking…
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 26, 2020
CareFusion 303 Alaris Syringe Module Model 8110 - Product Usage: is intended to provide recall — FDA Z-2823-2020
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 26, 2020
Precision Valve & Automation PVA, PREVENT is an FDA-authorized emergency ventilator designed recall — FDA Z-2805-2020
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being…
Class IIFDA: OngoingPrecision Valve & Automation, Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.