Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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Date	Product	Reason	Class	Firm
Oct 24, 2022	eSuction Small Cavity, Model ET2005	Improper device regulatory classification	Class II	Endo-Therapeutics, Inc.
Oct 12, 2022	OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-...	The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.	Class II	Novapproach Spine LLC
Sep 16, 2022	Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lo...	Blister package had an unsealed edge compromising sterility.	Class II	International Medical Industries, Inc.
Sep 1, 2022	Recreo Hair Growth Laser Comb	The firm distributed the laser products without affixing the warning, aperture, certification, an...	Class II	OMM Imports, Inc. dba Zero Gravity
Aug 30, 2022	Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.	When computing a radiation dose in the system, the exported dose information is incorrect when th...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Number...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Number...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Number...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 11, 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbe...	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac...	Class II	Exactech, Inc.
Aug 8, 2022	Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component ...	Certain units have the potential to exhibit infant failures whereby units either arrive non-funct...	Class II	Mako Surgical Corporation
Aug 3, 2022	LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - D...	Potential for intraoperative screw head separation at weld location.	Class II	Integrity Implants Inc.
Jul 19, 2022	Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.	Screws mounting an internal power supply may come loose during shipping resulting in increased ri...	Class II	Myolyn Inc.
Jun 28, 2022	HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1...	Battery performance issues. Battery electrical faults render it unable to power the controller, u...	Class I	Heartware, Inc.
Jun 22, 2022	(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in....	The product falls apart during handling after removal from its primary packaging.	Class II	ASO LLC
Jun 15, 2022	SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral...	Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to c...	Class I	North American Diagnostics
May 20, 2022	PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, ...	Potential for stent dislodgement and associated failures related to two specific sizes of the dev...	Class II	Cordis US Corp
May 3, 2022	NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2	Software anomaly was identified.	Class II	Medtronic Xomed, Inc.
May 3, 2022	NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2	Software anomaly was identified.	Class II	Medtronic Xomed, Inc.
Apr 29, 2022	NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ...	The firm received reports of events related to airway obstruction while using NIM Standard Reinfo...	Class I	Medtronic Xomed, Inc.
Apr 29, 2022	NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229...	The firm received reports of events related to airway obstruction while using NIM Standard Reinfo...	Class I	Medtronic Xomed, Inc.
Apr 29, 2022	NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)...	The firm received reports of events related to airway obstruction while using NIM Standard Reinfo...	Class I	Medtronic Xomed, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Nu...	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HV...	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14...	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONIT...	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 30, 2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14...	Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc...	Class II	Heartware, Inc.
Mar 25, 2022	K-Wire, 1.35 mm x 170 mm	Products do not meet length and diameter specifications.	Class II	Arthrex, Inc.
Mar 2, 2022	First Aid Kits containing acetaminophen under brand names Equate (Walmart), M...	Kits contained recalled acetaminophen.	Class II	ASO LLC
Feb 16, 2022	Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 1...	IRISpec CA failures for glucose.	Class III	Beckman Coulter, Inc.
Jan 27, 2022	LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-ca...	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone...	Class II	Integrity Implants Inc.
Jan 27, 2022	HeartWare Ventricular Assist Device (HVAD) System	Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B...	Class II	Heartware, Inc.
Jan 27, 2022	LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated....	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone...	Class II	Integrity Implants Inc.
Jan 27, 2022	LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul...	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone...	Class II	Integrity Implants Inc.
Dec 22, 2021	ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60	COVID test kits were offered for sale and distributed to consumers in the United States without m...	Class I	Empowered Diagnostics LLC
Dec 22, 2021	NIM TRIVANTAGE EMG Endotracheal Tube	There is potential for multiple issues due to a manufacturing nonconformity.	Class II	Medtronic Xomed, Inc.
Dec 22, 2021	CovClear COVID-19 Rapid Antigen Test, ATG 900-031	COVID test kits were offered for sale and distributed to consumers in the United States without m...	Class I	Empowered Diagnostics LLC
Dec 22, 2021	Destino Twist 14F (also branded as Guidestar 14F)	There is potential for separation between the threaded hub and threaded cap at the proximal end o...	Class II	Oscor Inc.
Dec 15, 2021	Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ...	As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei...	Class II	Medtronic Xomed, Inc.
Oct 1, 2021	SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is in...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis 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.