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
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.
Jan 9, 2023 ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita... 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 (REF)-For in vitro diagnostic use in the quan... 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 140 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.
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... Label with the incorrect component listed on the inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 22, 2022 ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno... Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or... Class II Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... Product Mislabeled on the outer bag and inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 20, 2022 CustomEyes kits Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Dec 20, 2022 Ultracell Wick with 80cc Collection Bag, 20/box Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 7, 2022 MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... Class I Covidien LP
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Dec 2, 2022 Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L Affected lots of the product are being recalled due to potential microbial growth in the fluid in... Class II Tomy International Inc.
Nov 30, 2022 Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... Class II Beaver Visitec International, Inc.
Nov 22, 2022 Philips Upgrade to MR 7700 System, Model Number 782130 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips MR 7700 System, Model Number 782120 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 21, 2022 Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... Class II Philips North America Llc
Nov 18, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... Class II Mobius Imaging, LLC
Nov 14, 2022 Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000... The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging... Class II Insulet Corporation
Nov 14, 2022 iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ... Class II Conformis, Inc.
Nov 8, 2022 FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 8, 2022 FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. ... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... 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.