Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle i... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | Brivo XR385, model 5215463, Digital Diagnostic Radiographic System | The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can i... | Class II | GE Healthcare, LLC |
| Sep 16, 2016 | Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 523... | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... | Class I | Vascular Solutions, Inc. |
| Sep 16, 2016 | Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized... | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... | Class I | Vascular Solutions, Inc. |
| Sep 16, 2016 | Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterili... | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... | Class I | Vascular Solutions, Inc. |
| Sep 16, 2016 | Proteus ONE and Proteus Plus | IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... | Class II | Ion Beam Applications S.A. |
| Sep 16, 2016 | BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid c... | An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20%... | Class II | Randox Laboratories |
| Sep 16, 2016 | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides photothe... | The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE b... | Class II | Natus Medical Incorporated |
| Sep 15, 2016 | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 ... | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match t... | Class II | Keystone Dental Inc |
| Sep 15, 2016 | Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Mod... | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire... | Class II | Battle Creek Equipment Co. |
| Sep 15, 2016 | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) i... | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 15, 2016 | SDMS (SenTec Digital Monitoring System) | Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Modu... | Class II | SenTec AG |
| Sep 15, 2016 | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx,... | Image data for a patients image may not be correct | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abut... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous ... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous denta... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An e... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dent... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abut... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseo... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on ... | Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect... | Class II | Roche Diabetes Care, Inc. |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJ... | A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam ... | Class II | Hand Biomechanics Lab Inc |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous denta... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An en... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental i... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous denta... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, 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.