Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Nov 19, 2014 Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower... HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 ... Class II Horiba Instruments Inc
Nov 19, 2014 Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
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 Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific 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 VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... Class II Ortho-Clinical Diagnostics
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 VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... Class II Ortho-Clinical Diagnostics
Nov 19, 2014 ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The... There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mAR... Class II Siemens Medical Solutions USA, 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 CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only M... KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component o... Class II KCI USA, INC.
Nov 19, 2014 Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLU... Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 20... Class II Natus Medical Incorporated
Nov 19, 2014 VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C... Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... Class II Ortho-Clinical Diagnostics
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 19, 2014 iPlan RT is a radiation treatment planning system that is intended for use in... iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us... Class II Brainlab AG
Nov 17, 2014 PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments ar... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments a... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopi... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 Lapa... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manu... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual In... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 Laparoscopic Manual ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instrum... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instr... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Ins... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. Laparoscopic Ma... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 Laparoscopic Ma... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Lap... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Man... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are int... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are inte... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instrument... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparosc... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are in... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 Laparoscopic Manu... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manu... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual In... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, BLUNT GRASPER, 20CM, P/N 0250282009 Laparoscopic Manual Ins... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 Laparoscopic... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. Laparoscopic Manual Instrumen... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual I... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy

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.