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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 5, 2023 UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... Class II Beckman Coulter, Inc.
Apr 5, 2023 iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C1068... Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sa... Class II Beckman Coulter, Inc.
Apr 5, 2023 DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diag... Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... Class II Beckman Coulter, Inc.
Mar 31, 2023 ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device In some cases the communication isolator installed in the Model 52X can cause a disturbance in th... Class II J&T Health and Wellness LLC
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 23, 2023 WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (s... The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclo... Class II ASO LLC
Feb 28, 2023 Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 An actuator separated from the pivot mechanism on a lower monitor boom system column and became d... Class II Omega Medical Imaging, Inc.
Feb 24, 2023 Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set ... Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a probl... Class II Iradimed Corporation
Feb 21, 2023 PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swa... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, RE... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety o... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 10, 2023 Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software... When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may de... Class II Sensus Healthcare, Inc.
Dec 20, 2022 RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX The product may be shorter than packaging indicates Class II Bolton Medical Inc.
Dec 20, 2022 RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX The product may be shorter than packaging indicates Class II Bolton Medical Inc.
Dec 7, 2022 Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone i... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMa... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Syste... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ S... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Pediatric Craniotome Ref:CRANI-P-G1 Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1104JP Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1205 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare Model 1102 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF MCS1705PU Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1104 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1103 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare Model 1101 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1104CA-CLIN Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare Model 1100 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 18, 2022 BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnost... Beckman Coulter has become aware of an increase in customer complaints generated for intermittent... Class II Beckman Coulter, 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.