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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.

Clear
DateProductReasonClassFirm
Jul 30, 2019 Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) ... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-104... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 m... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indic... Under certain conditions, a marble pattern infrequently appears on the monitor. Class II Eizo Corporation
Jul 30, 2019 RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Produc... Under certain conditions, a marble pattern infrequently appears on the monitor. Class II Eizo Corporation
Jul 30, 2019 Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) ... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 ... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
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 Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grai... The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (B... Class II MOTEK MEDICAL B.V.
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 26, 2019 Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated a... Fasteners potentially torqued to a value less than the specified value and can potentially cause ... Class II GE Healthcare, LLC
Jul 26, 2019 BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing ... An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... Class II Becton Dickinson & Co.
Jul 26, 2019 da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 26, 2019 BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing ... An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... Class II Becton Dickinson & Co.
Jul 26, 2019 da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 26, 2019 da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product U... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 25, 2019 Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF syst... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system i... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF s... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designe... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is des... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designe... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03... There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... Class II NeuroLogica Corporation
Jul 25, 2019 Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF syste... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is ... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed ... The seal integrity of the sterile bag containing the kits may be compromised. Class II Stryker GmbH
Jul 25, 2019 WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19... There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... Class II NeuroLogica 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.