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
Mar 22, 2023	VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS	There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ...	Class II	Covidien LP
Mar 22, 2023	VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS	There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ...	Class II	Covidien LP
Mar 22, 2023	VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS	There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ...	Class II	Covidien LP
Mar 20, 2023	Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814	Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi...	Class II	Philips North America
Mar 20, 2023	Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813	Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi...	Class II	Philips North America
Mar 17, 2023	CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. ...	Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permane...	Class II	Beaver Visitec International, Inc.
Mar 17, 2023	Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333	Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ...	Class II	Philips North America Llc
Mar 10, 2023	Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004	Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resu...	Class I	Fresenius Kabi USA, LLC
Mar 9, 2023	DigitalDiagnost C50 1.1-intended for use in generating radiographic images of...	If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo...	Class II	Philips North America Llc
Mar 9, 2023	Philips DigitalDiagnost C50 -intended for use in generating radiographic imag...	If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo...	Class II	Philips North America Llc
Mar 8, 2023	Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray S...	Issue related to the operation of the arm latch within the column that supports the arm, potentia...	Class II	NeuroLogica Corporation
Mar 6, 2023	EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 6, 2023	EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 3, 2023	CombiDiagnost R90 R1.1	Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ...	Class II	Philips North America
Mar 3, 2023	HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004	The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter e...	Class II	Access Vascular, Inc
Mar 3, 2023	CombiDiagnost R90 R.1.0	Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ...	Class II	Philips North America
Mar 3, 2023	ProxiDiagnost N90 R.1.0	Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ...	Class II	Philips North America
Feb 28, 2023	Omnipod 5 Automated Insulin Delivery System	An error message was received when using the Omnipod 5 App on compatible smartphones that prevent...	Class II	Insulet Corporation
Feb 27, 2023	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended f...	Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could ...	Class II	FUJIFILM Healthcare Americas Corporation
Feb 15, 2023	FoundationOne Companion Diagnostic (F1CDx)	An incorrect negative claim was identified on the claims page; the device variant information was...	Class II	Foundation Medicine, Inc.
Feb 3, 2023	ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in...	Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC...	Class II	Instrumentation Laboratory
Feb 3, 2023	ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis ...	Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC...	Class II	Instrumentation Laboratory
Feb 3, 2023	ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostas...	Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC...	Class II	Instrumentation Laboratory
Feb 3, 2023	ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the ...	Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC...	Class II	Instrumentation Laboratory
Feb 2, 2023	BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;	The field action was initiated in February of 2023 and was limited to the affected lot from sales...	Class II	Miach Orthopaedics
Feb 2, 2023	Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequen...	Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due t...	Class II	Boston Scientific Corporation
Jan 18, 2023	IntelliVue G7m Anesthesia Gas Module, Product Number 866173	The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an...	Class II	Philips North America
Jan 9, 2023	ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022	HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce...	Label with the incorrect component listed on the inner kit Tyvek header bag	Class II	Access Vascular, Inc
Dec 22, 2022	ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno...	Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022	HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc...	Product Mislabeled on the outer bag and inner kit Tyvek header bag	Class II	Access Vascular, Inc
Dec 20, 2022	CustomEyes kits	Device packaging may contain open seals, compromising product sterility.	Class II	Beaver Visitec International, Inc.
Dec 20, 2022	Ultracell Wick with 80cc Collection Bag, 20/box	Device packaging may contain open seals, compromising product sterility.	Class II	Beaver Visitec International, Inc.
Dec 16, 2022	HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001	Select catheter lots were identified to be labeled with incorrect expiration date, where the cath...	Class II	Access Vascular, Inc
Dec 16, 2022	HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002	Select catheter lots were identified to be labeled with incorrect expiration date, where the cath...	Class II	Access Vascular, Inc
Dec 16, 2022	HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002	Select catheter lots were identified to be labeled with incorrect expiration date, where the cath...	Class II	Access Vascular, Inc
Dec 12, 2022	epoc Host 2 as follows: Product SMN epoc NXS Host, US 11...	pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure	Class II	Siemens Healthcare Diagnostics Inc
Dec 12, 2022	epoc Host 2 as follows: Product SMN epoc Host 10736387 e...	pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure	Class II	Siemens Healthcare Diagnostics Inc
Dec 7, 2022	MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single...	There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ...	Class I	Covidien LP
Dec 7, 2022	MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra...	Stryker received one report of an injury to an untrained user that occurred while the untrained u...	Class II	Mobius Imaging, LLC
Dec 2, 2022	Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L	Affected lots of the product are being recalled due to potential microbial growth in the fluid in...	Class II	Tomy International Inc.
Nov 30, 2022	Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente...	Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility...	Class II	Beaver Visitec International, Inc.
Nov 22, 2022	Philips Upgrade to MR 7700 System, Model Number 782130	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc
Nov 22, 2022	Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78...	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc
Nov 22, 2022	Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	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.