Browse Device Recalls
3,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,550 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 3,550 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Jul 31, 2025 | Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Nam... | The potential of the elastic bands included in the kit detaching or fracturing during surgical pr... | Class II | Lumicell, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Cat... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catal... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 21, 2025 | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Ballo... | Potential for the balloon in the device to not meet burst specifications. | Class II | SUMMA THERAPEUTICS, LLC |
| Jul 7, 2025 | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some e... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 30, 2025 | Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Intera 3.0T Quasar Dual Model Number (REF): 781150; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Upgrade to MR 7700 Model Number (REF): 782130; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T S Model Number (REF): 781347; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for 3.0T Model Number (REF): 782145; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 26, 2025 | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot W... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 24, 2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 23, 2025 | Automated Impella Controller (AIC), used in left heart support blood pump, in... | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ... | Class I | Abiomed, Inc. |
| Jun 11, 2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... | Devices had an unapproved slabbing software function enabled for use. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jun 10, 2025 | BostonSight PROSE Lens. | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| Jun 10, 2025 | BostonSight SCLERAL Lens | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| May 29, 2025 | Achieva XR Product Numbers: (1) 781153, (2) 781253; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Omni/Stellar; Product Number: 781104; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Master/Nova Product Number: 781106; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera Achieva 1.5T Pulsar; Product Number: 781171; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova Product Number: 781172; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva IT Nova Product Number: 781175 | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | SmartPath to dStream for 1.5T¿; Product Number: 782146; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Explorer/Nova Dual Product Number: 781108; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova-Dual Product Number: 781173; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to conta... | Class II | Philips North America Llc |
| May 27, 2025 | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices m... | Class II | Medtronic Navigation, Inc.-Boxborough |
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.