Browse Device Recalls

88 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 88 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 88 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 23, 2019	IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affecte...	Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some I...	Class II	Philips North America, LLC
Jul 19, 2019	Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Produc...	The thickness of the connector to the trunk cable on affected limb lead sets may be greater than ...	Class II	Philips North America, LLC
Jul 16, 2019	HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The Hea...	Non-conforming devices are identified, which may not have been included in prior field actions an...	Class II	Philips North America, LLC
Jul 16, 2019	Philips Azurion systems with software version R1.2 -Interventional Fluorosc...	The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to t...	Class II	Philips North America, LLC
Jun 7, 2019	Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535...	The AC power module may fail at a higher than expected rate. If a fully charged battery is not p...	Class II	Philips North America, LLC
Apr 29, 2019	Philips Patient Information Center iX configured with a regional setting whic...	Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ...	Class III	Philips North America, LLC
Apr 29, 2019	Philips IntelliBridge System configured with a regional setting which uses a ...	Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ...	Class III	Philips North America, LLC
Apr 19, 2019	SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiolog...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological p...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the phys...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the p...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiolog...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring th...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the phy...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Apr 19, 2019	SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiologi...	System software inhibits the monitor and as a result does not measure, display and alarm for puls...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 12, 2019	Azurion FlexArm, 722079	During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not accor...	Class II	Philips North America, LLC
Feb 28, 2019	Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MR...	The locking plate may be missing from the system, which may result in unexpected stand/table tilt...	Class II	Philips North America, LLC
Feb 28, 2019	URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: Th...	The locking plate may be missing from the system, which may result in unexpected stand/table tilt...	Class II	Philips North America, LLC
Feb 28, 2019	MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 P...	The locking plate may be missing from the system, which may result in unexpected stand/table tilt...	Class II	Philips North America, LLC
Feb 28, 2019	Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product ...	The locking plate may be missing from the system, which may result in unexpected stand/table tilt...	Class II	Philips North America, LLC
Feb 28, 2019	MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a mul...	The locking plate may be missing from the system, which may result in unexpected stand/table tilt...	Class II	Philips North America, LLC
Jan 25, 2019	Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:...	Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturin...	Class II	Philips North America, LLC
Jan 25, 2019	Fetal Spiral Electrode, Model No. 9898 031 37631	During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a...	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis...	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio...	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi...	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis...	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC30, Product 860306, Software revisions up to and including A.07....	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC20, Product 860332, Software revisions up to and including A.07....	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC50, Product 860310, Software revisions up to and including A.07....	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jan 9, 2019	PageWriter TC70, Product 860315, Software revisions up to and including A.07....	Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ...	Class II	Philips North America, LLC
Jul 12, 2017	MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ...	Affected units may have a defective component that is intended to protect the internal circuitry ...	Class I	Philips North America, LLC
Feb 24, 2017	HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536...	HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si...	Class I	Philips North America, 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.