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 |
|---|---|---|---|---|
| May 10, 2019 | Replacement ECG leadwires with snap ends REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L... | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata... | Class I | Teleflex Medical |
| May 10, 2019 | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is in... | Potential for reporting low assay results | Class II | Phadia Ab |
| May 10, 2019 | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... | This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... | Class I | Medline Industries Inc |
| May 10, 2019 | Replacement leadwires with grabber ends: REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #8163290... | The glass syringe used with Pressure Control Syringes may potentially break during use. | Class II | Cadence Science, Inc. |
| May 10, 2019 | Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode... | Possible corrosion of the battery contact(s). | Class III | Cardiocommand Inc. |
| May 9, 2019 | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... | The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... | Class II | Abbott Laboratories |
| May 9, 2019 | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usa... | The titanium implant has the wrong article number laser marked on it. | Class II | I.T.S. GmbH |
| May 8, 2019 | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Prod... | This product has been contaminated with Stenotrophomonas lactiubi. | Class II | Madison Polymeric Engineering |
| May 8, 2019 | First Step Draco Pad, Product Number EP-4D | This product has been contaminated with Stenotrophomonas lactiubi. | Class II | Madison Polymeric Engineering |
| May 8, 2019 | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage... | These Instructions for Use has missing instructions related to the checking and changing of the a... | Class II | Xhale Assurance, Inc. |
| May 6, 2019 | RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit ... | The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of... | Class II | Qiagen Sciences, Inc. |
| May 6, 2019 | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294,... | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment... | Class I | Becton Dickinson & Company |
| May 6, 2019 | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 ... | User may suffer an electric shock when coming in contact with the exposed electronic components | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 6, 2019 | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85... | Potential issue related to the operation of the safety latch within the column that supports the ... | Class II | NeuroLogica Corporation |
| May 3, 2019 | AUTION HYBRID AU-4050 | This correction is being initiated due to a software issue which results in the possibility of in... | Class II | Arkray Factory USA, Inc. |
| May 3, 2019 | Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 3, 2019 | Leica Cryostats, used to produce frozen sample sections for biological, medic... | The current labelling does not include any specific warning about usage of flammable freezing spr... | Class II | Leica Microsystems, Inc. |
| May 3, 2019 | Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... | The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... | Class I | Medline Industries Inc |
| May 3, 2019 | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and hig... | Insulin dosing calculations were erroneously high. | Class II | Monarch Medical Technologies |
| May 3, 2019 | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Nu... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 3, 2019 | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERIL... | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (... | Class II | XTANT MEDICAL INC |
| May 3, 2019 | Accu-Chek Connect Diabetes Management App | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to t... | Class II | Roche Diabetes Care, Inc. |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displace... | After disconnection of a luer, the valve of the connector remains recessed; not fully closing, ei... | Class II | Becton Dickinson & Company |
| May 2, 2019 | SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for conti... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is ind... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - ... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - ... | Table assembly error with incorrect actuators for the lateral and longitudinal table movements | Class II | Oakworks Inc |
| May 2, 2019 | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT | The products may have been manufactured without the bottom seal on the outer packaging, compromis... | Class II | Cook Inc. |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated fo... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | SenTec Standard Starter Set with and without Service Gas (2 changers each) - ... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive b... | The product is unable to meet the use life of 31 cycles and may split or crack at the base of the... | Class II | Rinovum Women's Health |
| May 1, 2019 | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog ... | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint ... | Class I | B. Braun Medical, Inc. |
| May 1, 2019 | Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601... | Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunc... | Class II | Abbott Vascular |
| May 1, 2019 | Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX... | The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the syst... | Class II | Medtronic Navigation, Inc.-Littleton |
| May 1, 2019 | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ... | Class II | Abbott Laboratories, Inc |
| Apr 30, 2019 | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 338... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 30, 2019 | Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
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.