Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 27, 2019 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF... | The device label incorrectly states that the device is sterile. This product is an externally app... | Class III | Teleflex Medical |
| Feb 27, 2019 | MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with N... | Administration sets leaked at the filter. | Class II | Zevex Incorporated (dba MOOG Medical Devices Gr... |
| Feb 27, 2019 | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... | In certain occurrences, the affected navigation software application might unexpectedly display a... | Class I | Brainlab AG |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i... | The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... | Class II | Abbott Gmbh & Co. KG |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c... | The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... | Class II | Abbott Gmbh & Co. KG |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides... | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard ... | Class III | Nidek, Inc. |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitativ... | Reports have been received of lower MS2 MFI values when using the panel. | Class II | Luminex Molecular Diagnostics |
| Feb 22, 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ... | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc... | Class III | GE Healthcare, LLC |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 21, 2019 | icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: B... | BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect c... | Class II | Becton Dickinson & Co. |
| Feb 21, 2019 | icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE ... | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper... | Class II | ArthroCare Corporation |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channe... | Class II | Karl Storz Endoscopy |
| Feb 20, 2019 | ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an autom... | There is a potential for the device to generate Quality Control (QC) low or out-of-range low for ... | Class II | Abbott Laboratories |
| Feb 19, 2019 | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C ... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... | Class II | Philips Medical Systems Nederlands |
| Feb 19, 2019 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Prot... | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | Class II | The Binding Site Group, Ltd. |
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.