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 |
|---|---|---|---|---|
| Nov 19, 2014 | ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside ... | When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor... | Class II | Philips Electronics North America Corporation |
| Nov 19, 2014 | Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010... | Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting | Class II | ConforMIS, Inc. |
| Nov 19, 2014 | Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliV... | Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneou... | Class II | Philips Medical Systems, Inc. |
| Nov 19, 2014 | Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A | 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor... | Class II | Philips Medical Systems, Inc. |
| Nov 19, 2014 | Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... | MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid... | Class II | Philips Medical Systems, Inc. |
| Nov 19, 2014 | HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... | Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte... | Class II | Philips Medical Systems, Inc. |
| Nov 10, 2014 | MEVION S250, used for proton radiation therapy. | Software defect that causes an incorrect dose compensation function to be applied to the internal... | Class II | Mevion Medical Systems, Inc. |
| Nov 10, 2014 | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device *... | An increase in complaint trending for a loss of audible sound associated with the timer has been ... | Class II | CSA Medical |
| Oct 27, 2014 | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Num... | Drill set may contain incorrect drill. | Class II | Straumann USA, LLC |
| Oct 21, 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... | All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... | Class II | Gyrus Acmi, Incorporated |
| Oct 13, 2014 | Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K | Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ... | Class II | Medtronic Vascular |
| Oct 10, 2014 | Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an... | Mold on gel filled Gel-E and Squishon products | Class I | Philips Medical Systems, Inc. |
| Oct 9, 2014 | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System | If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light h... | Class II | Cynosure, Inc. |
| Oct 6, 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... | Class III | Siemens Healthcare Diagnostics, Inc |
| Oct 3, 2014 | Philips Avalon Monitors with software revision J.30.58: Model Product F... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Oct 3, 2014 | Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| Sep 26, 2014 | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335... | Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortis... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 24, 2014 | Foot Switches used with the following systems: Philips Allura Xper Systems; 7... | Loss of key image functionality due to a bent pedal of the Footswitch. | Class II | Philips Medical Systems, Inc. |
| Sep 24, 2014 | Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Arti... | Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) | Class II | Straumann USA, LLC |
| Sep 24, 2014 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... | Loss of key image functionality due to a bent pedal of the Footswitch. | Class II | Philips Medical Systems, Inc. |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status Power Supply Ad... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 19, 2014 | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Lox... | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) | Class II | Straumann USA, LLC |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status Connect System ... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status+ The Clinite... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 18, 2014 | Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:... | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | MediChoice¿ Multifunction Electrode Part Number: MC171 OH | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:... | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation E... | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pr... | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 15, 2014 | ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. C... | Increased imprecision and positive bias is observed with patient samples and negative controls an... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 15, 2014 | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage Sys... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Sep 15, 2014 | Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagno... | Increased imprecision and positive bias is observed with patient samples and negative controls an... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 15, 2014 | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Sy... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Sep 15, 2014 | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System)... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Sep 12, 2014 | ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ... | Stability of the ADVIA Centaur Cleaning Solution is not assured | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 21, 2014 | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... | When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Mod... | The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Mo... | The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... | Class II | Philips Medical Systems, Inc. |
| Aug 11, 2014 | Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant)... | Product not approved for use in the US | Class II | Instradent USA, Inc. |
| Aug 8, 2014 | Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system | Philips had discovered through a field service testing where a device failed to comply with a Fe... | Class II | Philips Medical Systems, Inc. |
| Aug 7, 2014 | Philips IntelliSpace ECG Management System, with software option C61 needed ... | Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... | It was discovered that a software defect may result in the scanner not terminating the CT scan a... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 45356044604... | Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 ... | Class II | Philips Electronics North America Corporation |
| Jul 15, 2014 | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... | Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrec... | Class II | Ab Sciex |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, 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.