Browse Device Recalls

3,378 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,378 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,378 FDA device recalls in MA.

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DateProductReasonClassFirm
Mar 15, 2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 13, 2024 BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... Safety Information: Complaints describe complications/adverse events that include pain, infection... Class I Hologic, Inc
Mar 12, 2024 Ingenia 3.0T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Master/Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 3.0T Quasar Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T10-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 0.5T Standard, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 5300, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Evolution Upgrade 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Initial, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T R11, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Conversion, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera CV, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0TX for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 7700, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Enterprise 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva XR, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 11, 2024 Identity 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... Class II Conformis, Inc.
Mar 11, 2024 OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... System error messages may delay the ability to test patient samples and the need for frequent cal... Class II Advanced Instruments, LLC
Mar 7, 2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... Class I Fresenius Kabi USA, LLC
Feb 28, 2024 Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... Class II Philips North America
Feb 28, 2024 CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... Class II Philips North America
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... Class II Magellan Diagnostics, Inc.
Feb 21, 2024 Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.