Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Va... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Azurion series (within the limits of the used Operation Room table) are i... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Vas... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for u... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Aug 3, 2021 | AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - ... | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideli... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 30, 2021 | Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for u... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicate... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 29, 2021 | LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB270... | Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment ... | Class II | Lymol Medical Corporation |
| Jul 20, 2021 | CritiCool, thermoregulation device | Premature pump failure may lead to the device displaying a HALT 4 error, from which the device ca... | Class II | Belmont Instrument Corporation |
| Jul 15, 2021 | (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Prod... | The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magne... | Class II | Philips North America |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the ... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the ... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 25, 2021 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodonti... | Product label intended for the European community was distributed to the USA market via their US ... | Class II | Straumann USA LLC |
| Jun 23, 2021 | Covidien Sonicision Reusable Generator-converts electrical power from the bat... | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of de... | Class II | Covidien Llc |
| Jun 16, 2021 | Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 7... | The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalp... | Class I | Cardinal Health 200, LLC |
| Jun 9, 2021 | Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU M... | A caution statement is being added to remind the user to activate away from face and infant as r... | Class II | Cardinal Health 200, LLC |
| Jun 9, 2021 | Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH000... | A caution statement is being added to remind the user to activate away from face and infant as r... | Class II | Cardinal Health 200, LLC |
| Jun 8, 2021 | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-r... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iC... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728332 IQon Spectral CT-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728333 Spectral CT 7500 -Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| May 27, 2021 | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless stee... | Tip of the screwdriver does not have the correct configuration / profile therefore the screwdrive... | Class II | Straumann USA LLC |
| May 26, 2021 | Azurion systems with software release R2.0.x | In the Azurion system, the user can add a new study to a patient by selecting the option "Add Stu... | Class II | Philips Healthcare |
| May 26, 2021 | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used wi... | Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refil... | Class II | Flowonix Medical Inc |
| May 7, 2021 | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan 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.