Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 24, 2023 | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... | Class III | Fresenius Medical Care Holdings, Inc. |
| Oct 23, 2023 | Intera 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Intera 1.5T Power/Pulsar | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T Conversion | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T Initial System | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Ingenia 1.5T CX | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | SmartPath to dStream for 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 19, 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 17, 2023 | Lugol s Iodine Solution 500ML, Part Number 624-71 | Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap ... | Class II | EMD Millipore Corporation |
| Oct 13, 2023 | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 0060... | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficien... | Class II | Breas Medical, Inc. |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-000-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-040-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Oct 10, 2023 | Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025 | One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly cont... | Class II | Beaver Visitec International, Inc. |
| Oct 10, 2023 | Stay Safe Cap | Updating the labeling to include additional warnings and contraindications for potential side eff... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 9, 2023 | Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... | Class II | Philips North America |
| Oct 9, 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... | Class II | Philips North America |
| Oct 4, 2023 | Integris-Allura IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Azurion IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Zenition 50 & 70 Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Veradius Unity Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Allura Xper IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inne... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box U... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 26, 2023 | RAPIDPOINT 500e Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 26, 2023 | RAPIDPOINT 500 Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 21, 2023 | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America 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.