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 |
|---|---|---|---|---|
| May 3, 2024 | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Initial system Model Number (REF): 781178 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems i... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical System... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indi... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 78210... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak II-Patient transport functionality to transport the patient from ... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 30, 2024 | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Oper... | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Pa... | Class I | ZOLL Medical Corporation |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System... | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System... | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 19, 2024 | Patient Information Center iX and Patient Information Center iX Expand, Softw... | Event Catalog information does not save when copied and transferred from one unit to another. | Class II | Philips North America Llc |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular gra... | The guide tip can become damaged and result in the tip detaching. | Class II | LeMaitre Vascular, Inc. |
| Apr 17, 2024 | Blood Pump Rotor, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Apr 11, 2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 11, 2024 | FDR Visionary Suite - Intended to generate digital or conventional radiograph... | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, co... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 8, 2024 | Novalung sensor box is a component of the Novalung Console (F30000162)-Indica... | Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 2, 2024 | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) | A packaging seal gap could impact the sterility of the product. | Class II | Andover Healthcare Inc. |
| Mar 29, 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Potential for third party oncology marking laser to be reflected off the gantry cover surface, wh... | Class II | Philips North America Llc |
| Mar 26, 2024 | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | Complaints have been received with allegations of Incorrect Needle Curvature. | Class II | SURGICAL SPECIALTIES |
| Mar 22, 2024 | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS... | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information... | Class II | Philips North America Llc |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
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.