Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | There is a potential that users may experience difficulty validating the calibration of the kit. ... | Class II | The Binding Site Group, Ltd. |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 24, 2019 | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the im... | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn po... | Class II | Exactech, Inc. |
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-47... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Jul 12, 2019 | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... | Class II | ICU Medical, Inc. |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 1, 2019 | LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jun 27, 2019 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... | It has been determined that some Pedicle system screw identified as 45mm long have an actual len... | Class II | Medicrea International |
| Jun 12, 2019 | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO ... | There is a potential for the device to fail to deliver energy to the patient. | Class II | ZOLL Medical Corporation |
| Jun 3, 2019 | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 3... | The products have been confirmed to have reduced or no additive within the tube reservoir. The t... | Class II | Becton Dickinson & Company |
| Jun 1, 2019 | Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Hepari... | False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutaine... | Class II | Centurion Medical Products Corporation |
| May 29, 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... | Class II | AtriCure, Inc. |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 17, 2019 | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 10, 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode... | Possible corrosion of the battery contact(s). | Class III | Cardiocommand Inc. |
| Apr 26, 2019 | Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-10... | may contain a damaged gray safety lock knob, which could potentially result in difficulty or an i... | Class II | Cook Inc. |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 3, 2019 | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article ... | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become ... | Class II | Thommen Medical AG |
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.