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 |
|---|---|---|---|---|
| Apr 25, 2023 | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c... | Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to b... | Class II | LumiraDx |
| Apr 19, 2023 | Patient Information Center iX, Product Code 866386, and Patient Information C... | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... | Class II | Philips North America |
| Apr 17, 2023 | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. | Class I | Abiomed, Inc. |
| Apr 13, 2023 | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 13, 2023 | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 13, 2023 | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 13, 2023 | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 13, 2023 | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 12, 2023 | Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Nu... | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... | Class II | PHILIPS HEADQUARTERS CAMBRIDGE |
| Apr 12, 2023 | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Nu... | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... | Class II | PHILIPS HEADQUARTERS CAMBRIDGE |
| Apr 12, 2023 | Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: ... | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... | Class II | PHILIPS HEADQUARTERS CAMBRIDGE |
| Apr 12, 2023 | Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: ... | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... | Class II | PHILIPS HEADQUARTERS CAMBRIDGE |
| Apr 7, 2023 | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring Sys... | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially lea... | Class II | Cytrellis Biosystems, Inc. |
| Apr 5, 2023 | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Apr 5, 2023 | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Mar 29, 2023 | binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Ch... | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis ... | Class II | Binx Health, Inc. |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 17, 2023 | CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. ... | Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permane... | Class II | Beaver Visitec International, Inc. |
| Mar 17, 2023 | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ... | Class II | Philips North America Llc |
| Mar 10, 2023 | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resu... | Class I | Fresenius Kabi USA, LLC |
| Mar 9, 2023 | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 9, 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic imag... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 8, 2023 | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray S... | Issue related to the operation of the arm latch within the column that supports the arm, potentia... | Class II | NeuroLogica Corporation |
| Mar 6, 2023 | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 6, 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 3, 2023 | CombiDiagnost R90 R1.1 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter e... | Class II | Access Vascular, Inc |
| Mar 3, 2023 | CombiDiagnost R90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | ProxiDiagnost N90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Feb 28, 2023 | Omnipod 5 Automated Insulin Delivery System | An error message was received when using the Omnipod 5 App on compatible smartphones that prevent... | Class II | Insulet Corporation |
| Feb 27, 2023 | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended f... | Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could ... | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 15, 2023 | FoundationOne Companion Diagnostic (F1CDx) | An incorrect negative claim was identified on the claims page; the device variant information was... | Class II | Foundation Medicine, Inc. |
| Feb 3, 2023 | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostas... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 2, 2023 | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; | The field action was initiated in February of 2023 and was limited to the affected lot from sales... | Class II | Miach Orthopaedics |
| Feb 2, 2023 | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequen... | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due t... | Class II | Boston Scientific Corporation |
| Jan 18, 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an... | Class II | Philips North America |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | 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.