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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,506 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,506 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 1,506 FDA device recalls in FL.

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DateProductReasonClassFirm
Apr 2, 2015 Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Cli... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Pat... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialy... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Onco... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco XL Convalescent Recliner - with Steel Casters Long term patient reclin... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Reco... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Mar 30, 2015 NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protec... Blood foaming was found during evaluation of the product. Class II Nipro Medical Corporation
Mar 26, 2015 Diamedix Is-CMV IgG Test Kit Product contained an incorrect substrate. Class II Diamedix Corporation
Mar 24, 2015 Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532... The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive... Class II The Anspach Effort, Inc.
Mar 17, 2015 American Catheter / Cholangiogram Catheter 9100 Series. Catheters were not sealed before sterilization. and was not detected through subsequent acceptanc... Class II American Catheter Corp
Mar 5, 2015 Sony Medical Monitor LMD-1951MD 19 inch Monitor has either not turned on or has lost image during clinical use. Class II Sony Latin America
Feb 25, 2015 Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. Nonapproved labeling claims (Sterile) Class II Amerx Health Care Corp.
Feb 25, 2015 Captiva's lumbar intervertebral fusion system Reamers (color code rings on th... It is possible for the titanium color-coded ring to detach from the Reamers. Class II Captiva Spine, Inc
Feb 13, 2015 Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic... Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed... Class II Exactech, Inc.
Jan 23, 2015 Bio-MAC Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, Inc
Jan 23, 2015 Bio-PLASTY Cannula (Needle) Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, Inc
Jan 23, 2015 Bio-CORE Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, Inc
Jan 22, 2015 Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Ro... When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outs... Class II Mako Surgical Corporation
Jan 16, 2015 HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: ... The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commerc... Class I HeartWare Inc
Dec 23, 2014 FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limite... Product distributed without 510(k) approval Class II Therasage, LLC.
Dec 23, 2014 Portable FAR Infrared Sauna Indications including, but not limited to Natura... Product distributed without 510(k) approval Class II Therasage, LLC.
Dec 23, 2014 FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limite... Product distributed without 510(k) approval Class II Therasage, LLC.
Dec 22, 2014 Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses i... One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was ... Class II Cordis Corporation
Dec 10, 2014 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting a... Customer complaint indicating the color bands on the MIA16-G1 were not correct. Class II The Anspach Effort, Inc.
Dec 5, 2014 Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial inse... Presence of one inoperable (dead) sensor pad. Class II Orthosensor, Inc.
Nov 26, 2014 SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10,... Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report se... Class II SCC Soft Computer
Nov 14, 2014 Synthes Small Electric Drive (SED) May operate solely in reverse mode, not operate in reverse mode when intended, not function or an... Class II The Anspach Effort, Inc.
Nov 7, 2014 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm ... Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
Nov 7, 2014 OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants. Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
Nov 7, 2014 OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental ... Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
Oct 23, 2014 Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determin... Product is not performing according to specifications. Control 2 does not consistently recover wi... Class II JAS Diagnostics Inc.
Oct 22, 2014 Philips Expression MR200 MRI Patient Monitoring System. The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; po... Class II Invivo Corporation
Oct 20, 2014 Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Oct 20, 2014 Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EI... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Oct 20, 2014 Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Re... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, 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.