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
Mar 11, 2014 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm)... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... Class II Philips Medical Systems (Cleveland) Inc
Mar 11, 2014 5/10 Weck¿ Vista" Universal Balloon Open Access Port  Short Length (53mm), ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Steril... Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... Class II Teleflex Medical
Mar 11, 2014 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 40... Complaints of leakage of insufflation gas through the device. Class II Teleflex Medical
Mar 11, 2014 Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgic... Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... Class II Teleflex Medical
Mar 11, 2014 Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usa... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synt... The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Class II Teleflex Medical
Mar 11, 2014 Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Prod... The products are being recalled because they did not meet minimum needle attachment strength requ... Class II Teleflex Medical
Mar 11, 2014 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122... The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Class II Teleflex Medical
Mar 11, 2014 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Produ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless... Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... Class II Teleflex Medical
Mar 11, 2014 Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Prod... The products are being recalled because they did not meet minimum needle attachment strength requ... Class II Teleflex Medical
Mar 10, 2014 Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ ... Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert i... Class II Integra LifeSciences Corp.
Mar 10, 2014 Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC V... Slippage of the radius drive belt in the relative 180 degree orientation of the superior position... Class II Philips Medical Systems (Cleveland) Inc
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on the user interface ... Class I Del Mar Reynolds Medical, Ltd.
Mar 8, 2014 Neusoft NeuViz 64 Multi-slice CT Scanner System The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing... Class II Neusoft Medical System Co
Mar 7, 2014 Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E c... ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includ... Class II Siemens Medical Solutions USA, Inc.
Mar 7, 2014 Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc... One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp whi... Class II Clarity Medical Systems Inc
Mar 7, 2014 NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Ca... The femoral stem is lacking specified plasma coating. Class II Exactech, Inc.
Mar 6, 2014 API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 FB Reagent (REF 70562). FB reagent is an additional test used for revealin... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2014 API Listeria (REF 10300). ZYM B reagent is used and included inside of API... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 6, 2014 ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to... bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... Class II BioMerieux SA
Mar 5, 2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used Class II ZOLL Medical Corporation
Mar 5, 2014 VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Di... The firm identified a potential for biased carbamazepine (CRBM) results to be generated when usin... Class II Ortho-Clinical Diagnostics
Mar 5, 2014 Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted an... Class I Draeger Medical Systems, Inc.
Mar 5, 2014 AXIOM Vertix MD Trauma systems radiographic X-ray There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma ... Class II Siemens Medical Solutions USA, Inc
Mar 5, 2014 DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor us... The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. Class II Mindray DS USA, Inc. dba Mindray North America
Mar 5, 2014 FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. El... Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically... Class II Remington Medical Inc.
Mar 5, 2014 Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... The outer package label contained the incorrect length of the device. There is a label on the out... Class II Pega Medical Inc.
Mar 5, 2014 Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product ... Extremely low absorbance readings. Class II Alfa Wassermann, Inc.
Mar 5, 2014 MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Pr... Geometric positioning error can occur after a rotational correction has been applied to one or mo... Class II Mevion Medical Systems, Inc.
Mar 5, 2014 Symbia T and Symbia T2 computer tomography systems. These systems are used to... There are confirmed reports of a component coming loose inside the CT enclosure and damaging the ... Class II Siemens Medical Solutions USA, Inc.
Mar 5, 2014 Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product ... Extremely low absorbance readings. Class II Alfa Wassermann, Inc.
Mar 4, 2014 Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 PCP Test (Strip); LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800... Sterility of the product cannot be guaranteed. Class II Teleflex Medical
Mar 4, 2014 THC Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Cocaine Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) w... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation

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.