Browse Device Recalls

3,378 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,378 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 3,378 FDA device recalls in MA.

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Date	Product	Reason	Class	Firm
Jun 1, 2023	epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N...	There is potential for discrepant high glucose results in samples with glucose results on the low...	Class II	Siemens Healthcare Diagnostics Inc
Jun 1, 2023	epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens...	There is potential for discrepant high glucose results in samples with glucose results on the low...	Class II	Siemens Healthcare Diagnostics Inc
May 26, 2023	Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457	There was one complaint that the sidearm of the device detached during explant of a pump. When t...	Class II	Abiomed, Inc.
May 25, 2023	Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device th...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device tha...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a ...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 25, 2023	Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a d...	Manufactured with the incorrect component may result in lower power output and degradation or dim...	Class II	Boston Scientific Corporation
May 23, 2023	SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 23, 2023	PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1...	Possible out of specification endotoxin test results due to issues with in-process and finished g...	Class II	TEI Biosciences, Inc.
May 19, 2023	DigitalDiagnost C90, Model No. 712034 and 712035	There is a software login in issue that may prevent the user from logging in.	Class II	Philips North America Llc
May 10, 2023	LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004	Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S...	Class II	Fresenius Kabi USA, LLC
May 2, 2023	Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy sa...	The inner needle of the Sertera device is either detaching or discharging and may cause delay in ...	Class II	Hologic, Inc
Apr 25, 2023	Incisive CT Plus-Computed Tomography X-Ray System Model: 728149	Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci...	Class II	Philips North America
Apr 25, 2023	Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148	Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci...	Class II	Philips North America
Apr 25, 2023	Incisive CT-Computed Tomography X-Ray System Model: 728143	Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci...	Class II	Philips North America
Apr 25, 2023	Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146	Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci...	Class II	Philips North America
Apr 25, 2023	SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c...	Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to b...	Class II	LumiraDx
Apr 19, 2023	Patient Information Center iX, Product Code 866386, and Patient Information C...	During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto...	Class II	Philips North America
Apr 17, 2023	Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p...	The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.	Class I	Abiomed, Inc.
Apr 13, 2023	DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone...	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023	DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to...	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023	DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ...	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023	DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f...	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023	DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ...	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 12, 2023	Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Nu...	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m...	Class II	PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023	Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Nu...	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m...	Class II	PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023	Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: ...	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m...	Class II	PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023	Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: ...	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m...	Class II	PHILIPS HEADQUARTERS CAMBRIDGE
Apr 7, 2023	Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring Sys...	Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially lea...	Class II	Cytrellis Biosystems, Inc.
Apr 5, 2023	Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia...	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ...	Class II	Draeger Medical Systems, Inc.
Apr 5, 2023	Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls...	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ...	Class II	Draeger Medical Systems, Inc.
Mar 29, 2023	binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Ch...	May not meet the declared performance characteristics for the detection of Chlamydia trachomatis ...	Class II	Binx Health, Inc.

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.