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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.