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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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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

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Apr 17, 2020 Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Const... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 15, 2020 Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Numb... The firm received complaints on five devices from one specific lot where the stent dislodged from... Class II Cook Inc.
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Mar 6, 2020 Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-... The printed expiration dates are incorrect. Class II Cook Inc.
Mar 6, 2020 Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Nu... The printed expiration dates are incorrect. Class II Cook Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, S... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, S... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, ... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, ... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 25, 2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper A... Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may ... Class II Biomet, Inc.
Feb 17, 2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Prod... A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. Class II Biomet, Inc.
Feb 12, 2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... Proximal end of the driver in the affected product may be oversized in varying degrees, potentia... Class II Nextremity Solutions
Feb 7, 2020 Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immu... The firm has received an increased number of complaints concerning non-reproducible elevated resu... Class II Roche Diagnostics Operations, Inc.
Jan 21, 2020 PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Pr... The firm is removing the product from the market after discussions with the FDA due to lack of 51... Class II Polymer Technology Systems, Inc.
Jan 19, 2020 Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and t... Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay p... Class II EHOB, Inc.
Jan 16, 2020 Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is a... The firm has identified factors which contributed to failures relating to thrombus formation and/... Class II Cook Inc.
Jan 7, 2020 cobas infinity core, Material No. 7154003001. The device is a calculator/data... Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Valid... Class II Roche Diagnostics Operations, Inc.
Jan 7, 2020 THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... Potential increase in fracture rate was detected during internal testing, in addition to potentia... Class II Zimmer Biomet, Inc.
Jan 3, 2020 SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product i... The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in... Class II DePuy Orthopaedics, Inc.
Dec 27, 2019 Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3... Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, whi... Class II Cook 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.