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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.