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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

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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
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm 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- 50mm Rt Narrow Ti Mand Rec... 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 Narrow Ti Mand Rec... 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 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 16, 2014 Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head f... Report received where the Align Radial Stem fractured. Class II Skeletal Dynamics
Oct 10, 2014 Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable I... Several complaints regarding the IV sets leaking at the Y site. Class II US Infusion Inc dba Trucare Biomedix-USA
Oct 9, 2014 Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, C... Mislabeled Class II Exactech, Inc.
Oct 7, 2014 RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable i... MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class II Mako Surgical Corporation
Oct 7, 2014 RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable ins... MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class II Mako Surgical Corporation
Oct 7, 2014 RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument de... MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class II Mako Surgical Corporation
Sep 29, 2014 Dharma Cavity Varnish with Fluoride During an FDA inspection, it was found that the products are being marketed without a cleared 510k. Class II Dharma Research, Inc.
Sep 29, 2014 Dharma Cavity Varnish 15mL During an FDA inspection it was found that the products are marketed without a cleared 510k. Class II Dharma Research, Inc.
Sep 26, 2014 Amerigel Daily Dressing Packets Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Hydrogel Wound Dressing Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Post-op Surgical Kits Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Saturated Gauze Dressing Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 22, 2014 Digital Mobile X-ray Systems used to take diagnostic radiographic exposures o... There is a potential for unintended and erratic motion. Class II Virtual Imaging, Inc.
Sep 14, 2014 Philips Expression Information Portal (IP5) Model 865471. The IP5 is intend... Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notificati... Class II Invivo Corporation
Sep 10, 2014 Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, ... A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len... Class II Intertrade Imports Inc.
Sep 10, 2014 Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Ad... A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len... Class II Intertrade Imports Inc.
Sep 8, 2014 Philips Expression MR200 MRI Patient Monitoring System Model 866120 During production, excess metal (aluminum) debris was found stuck to the cling plastic that cover... Class II Invivo Corporation
Sep 5, 2014 Philips Expression MR200 MRI Patient Monitoring System Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. Class II Invivo Corporation
Aug 15, 2014 ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JR... Potential issues with the ProVue driver have been identified which may cause data to be misassoci... Class II Data Innovations, LLC
Aug 14, 2014 Synthes Small Electric Drive (SED). For use in general traumatology. The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in revers... Class II The Anspach Effort, Inc.
Aug 13, 2014 RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for pat... Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval noti... Class II Smith & Nephew, Inc.
Aug 8, 2014 IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is ... Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. Class II Sun Nuclear Corporation
Aug 8, 2014 The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usag... The firm is distributing the Rejuvenator device without an approved 510(k). Class II Baro-Therapies, Inc
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Prod... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage:... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage:... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 11, 2014 Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amer... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads siz... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jun 30, 2014 Philips IP5 Information Portal The Expression Information Portal (Model IP... The wireless function of the IP5 radio could be interrupted causing loss of wireless communicatio... Class II Invivo Corporation
Jun 27, 2014 Life Force Chamber Product Usage:The product is intended for restful cont... The Life Force chamber is marketed and promoted as a medical device, intended for use in the diag... Class II Life Force of Tampa, LLC
Jun 25, 2014 BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut... Identifiers on the label are correct but the label has the incorrect color coding. Class II Biomet 3i, LLC
Jun 23, 2014 Cordis EMPIRA RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... Class II Cordis Corporation
Jun 23, 2014 Cordis EMPIRA NC RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... Class II Cordis Corporation
May 20, 2014 SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory infor... The interface fails to send abnormal flags for Reference Lab test results. Class II SCC Soft Computer
May 8, 2014 Anspach Pneumatic and Electric Motor Systems. Intended for cutting and sha... Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) wh... Class II The Anspach Effort, Inc.
May 6, 2014 Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim ... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Photonica Light Modulator. These include all products labeled as UltraSlim, L... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
Apr 30, 2014 Robotic Arm Interactive Orthopedic System (RIO) Revision of the field manual Class II Mako Surgical Corporation
Apr 16, 2014 HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart... Patients and caregivers are instructed that if a battery does not provide two hours of support or... Class II HeartWare Inc
Apr 15, 2014 RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patient... Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the h... Class II Cordis Corporation
Apr 7, 2014 Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination... JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to cer... Class II JAS Diagnostics Inc.
Apr 1, 2014 NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. Device has the potential to have torn wings. Class III Nipro Medical Corporation
Mar 28, 2014 Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usa... Problem with low adhesion of the tubing to luer connection which may lead to a separation of the... Class II RGI Medical Manufacturing, 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.