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.

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DateProductReasonClassFirm
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.