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 |
|---|---|---|---|---|
| Jun 3, 2024 | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part... | 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. |
| Jun 3, 2024 | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part,... | 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. |
| Jun 3, 2024 | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare ... | 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. |
| Jun 3, 2024 | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare p... | 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. |
| May 31, 2024 | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... | Nine (9) Impella CP pumps failed inspection and were inadvertently released. | Class I | Abiomed, Inc. |
| May 22, 2024 | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the f... | Potential for inaccurate fetal heart rate measurements when monitoring multiples. | Class II | Philips North America Llc |
| May 17, 2024 | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... | Class II | Siemens Healthcare Diagnostics Inc |
| May 16, 2024 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point ran... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 14, 2024 | NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Cata... | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two ... | Class II | NxStage Medical Inc |
| May 13, 2024 | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power... | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standa... | Class II | Draeger Medical Systems, Inc. |
| May 10, 2024 | Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a compone... | The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... | Class II | Beaver Visitec International, Inc. |
| May 10, 2024 | Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227 | The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... | Class II | Beaver Visitec International, Inc. |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | 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 TX for PET Model Number (REF): 781479 | 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 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | 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 1.5T S Model Number (REF): 781347 | 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 Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | 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 XR and 3.0T- Magnetic Resonance (MR) systems are Med... | 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 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4... | 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 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | 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 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. |
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.