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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

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

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DateProductReasonClassFirm
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.
Mar 25, 2014 IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the managem... Potential for microbial contamination of the product. Class I Wellspring Pharmaceutical Corporation
Mar 21, 2014 LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system... While projecting yellow lines it was notice that the yellow projection has the potential to split... Class II LAP of America Laser Applications, LLC
Mar 21, 2014 Amerigel Wound Dressing 55 gallons/drum Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
Mar 21, 2014 Amerigel Wound Dressing 1 oz. tube Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
Mar 19, 2014 Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgica... The support arm attached with an adhesive to the body of the blade is detaching while attempting ... Class II Biorep Technologies
Mar 7, 2014 NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Ca... The femoral stem is lacking specified plasma coating. Class II Exactech, Inc.
Feb 11, 2014 AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nit... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, LLC
Feb 11, 2014 AMS AST For the In vitro quantitative determination of AST in serum Quant... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, LLC
Feb 11, 2014 AMS URIC ACID For the In vitro quantitative determination of Uric Acid in ser... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, LLC
Jan 29, 2014 SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMi... When an isolate is resulted without a SNOMED code, isolate information in the downstream system m... Class II SCC Soft Computer
Jan 9, 2014 Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS So... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s:... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dress... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 668... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being used. Class II Mako Surgical Corporation
Jan 8, 2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with L... Anspach product code L-3SD contained product code S-3SD which is shorter in length than the label... Class II The Anspach Effort, Inc.
Jan 6, 2014 Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cer... The products have been identified to contain springs which have been manufactured with type-304 s... Class II Exactech, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended par... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Dru... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes -... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 6, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... The housing to the Pump's driveline connector became partially or fully separated from the front ... Class I HeartWare Inc
Dec 6, 2013 ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony de... RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may cont... Class II RTI Surgical, Inc.
Dec 4, 2013 Invivo Corporation Expression Information Portal (Model IP5) is intended to b... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi... Class II Invivo Corporation
Dec 3, 2013 Lumbar Extension Machine for Physical Therapy Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on... Class II MedX Holdings, Inc.
Dec 3, 2013 Cervical Extension Machine for Physical Therapy Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on... Class II MedX Holdings, Inc.
Dec 3, 2013 Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a meth... The Irrigation Clips were assembled with the incorrect (smaller) clips. Class II The Anspach Effort, Inc.
Nov 21, 2013 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fl... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoro... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile ... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluorosc... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mob... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 14, 2013 Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew Inc.
Nov 14, 2013 Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew Inc.
Oct 16, 2013 Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for p... Lens was manufactured with incorrect raw material. Class II Bausch & Lomb Surgical, Inc.
Oct 7, 2013 CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP iso... Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso ... Class II LAP of America Laser Applications, 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.