Medical DeviceApr 13, 2022
Abbott Molecular Alinity m HBV AMP Kit (US and CE) recall — FDA Z-0884-2022
There is a potential for misquantitation high results for negative samples.
Class IIFDA: OngoingAbbott Molecular, Inc.
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 441
24,239 detailed records are currently available in this category.
Medical DeviceApr 13, 2022
GE Healthcare SIGNA Excite 3T. Magnetic Resonance Imaging System recall — FDA Z-0859-2022
There is potential for the images to be flipped left to right.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceApr 13, 2022
WHPM First SIGN SARS-CoV-2 Antigen Test recall — FDA Z-0892-2022
Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA…
Class IIFDA: TerminatedWHPM Inc.
Medical DeviceApr 13, 2022
GE Healthcare 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD recall — FDA Z-0858-2022
There is potential for the images to be flipped left to right.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceApr 13, 2022
Brius Patient Specific Brackets recall — FDA Z-0889-2022
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Class IIFDA: TerminatedBrius Technologies Inc.
Medical DeviceApr 13, 2022
Hologic Panther Fusion GBS Assay Cartridges 96 Tests recall — FDA Z-0877-2022
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceApr 13, 2022
Shimadzu Medical Systems MODEL: X-RAY TV SYSTEM SONIALVISION G4 recall — FDA Z-0868-2022
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in…
Class IIFDA: OngoingShimadzu Medical Systems
Medical DeviceApr 13, 2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic recall — FDA Z-0878-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 13, 2022
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software recall — FDA Z-0737-2022
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on…
Class IIFDA: TerminatedPhilips Healthcare
Medical DeviceApr 13, 2022
Philips recall — FDA Z-0881-2022
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 13, 2022
Cook Medical Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog recall — FDA Z-0875-2022
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Class IIIFDA: TerminatedCook Medical Inc.
Medical DeviceApr 13, 2022
Ventana Medical Systems BenchMark ULTRA and DISCOVERY ULTRA Instruments recall — FDA Z-0894-2022
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
Class IIFDA: OngoingVentana Medical Systems Inc.
Medical DeviceApr 13, 2022
Philips recall — FDA Z-0882-2022
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 13, 2022
GE Healthcare 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile recall — FDA Z-0860-2022
There is potential for the images to be flipped left to right.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceApr 13, 2022
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT recall — FDA Z-0876-2022
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Class IIIFDA: TerminatedCook Medical Inc.
Medical DeviceApr 13, 2022
Philips Allura recall — FDA Z-0874-2022
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 13, 2022
Draeger Medical Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the recall — FDA Z-0871-2022
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceApr 13, 2022
MEDLINE INDUSTRIES, LP - Northfield Excelsior Medical 10mL Sterile Field Saline Flush ZR recall — FDA Z-0898-2022
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 13, 2022
Abbott Molecular Alinity m HBV Application Specification File (US and CE) recall — FDA Z-0883-2022
There is a potential for misquantitation high results of negative samples.
Class IIFDA: OngoingAbbott Molecular, Inc.
Medical DeviceApr 13, 2022
Maquet Medical Systems USA Cardiohelp-i Transport Guard with Transport Guard (701072525): is recall — FDA Z-0897-2022
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully…
Class IIFDA: OngoingMaquet Medical Systems USA
Medical DeviceApr 13, 2022
Brius Technologies Customized Brius Appliances recall — FDA Z-0890-2022
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Class IIFDA: TerminatedBrius Technologies Inc.
Medical DeviceApr 13, 2022
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic recall — FDA Z-0880-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 13, 2022
Brius Pontics recall — FDA Z-0888-2022
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Class IIFDA: TerminatedBrius Technologies Inc.
Medical DeviceApr 13, 2022
Siemens Medical Solutions USA Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems recall — FDA Z-0893-2022
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Class IIFDA: TerminatedSiemens Medical Solutions USA, 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.