Medical device recalls
39048 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-04-24FDA-DeviceSmith & Nephew Medical, Ltd.Class IIRENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- 2024-04-24FDA-DeviceRaye's Inc.Class IISW Bari Lift & Transfer, Model Number 38060000
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
- 2024-04-24FDA-DeviceRandox Laboratories Ltd.Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- 2024-04-24FDA-DeviceRandox Laboratories Ltd.Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- 2024-04-24FDA-DeviceACTIM OYClass IIActim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
- 2024-04-24FDA-DeviceConformis, Inc.Class IIIdentity Imprint PS Tibial Tray Size 4: Lot 540287
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
- 2024-04-24FDA-DevicePhilips North America LlcClass IISmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IISmartPath to dStream for 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIMR 7700, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIMR 5300, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera CV, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera Achieva 1.5T Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 3.0T Quasar Dual, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T R11, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Power/Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Omni/Stellar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Master/Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Achieva Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T Achieva IT Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.0T Power/Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 1.0T Omni/Stellar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIntera 0.5T Standard, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIngenia Elition X, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIngenia Elition S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIngenia Ambition X, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIngenia Ambition S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIIngenia 3.0T CX, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief