Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

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.

Clear
DateProductReasonClassFirm
Aug 16, 2022 Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 14, 2022 cobas e801 Immunoassay Analyzer Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... Class II Roche Diagnostics Operations, Inc.
Jun 29, 2022 Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fract... Class II OrthoPediatrics Corp
Jun 29, 2022 ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio... Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless stee... Class II DePuy Orthopaedics, Inc.
May 25, 2022 Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C... The products may contain excess coating material on the outside and/or interior of the needle com... Class II Cook Incorporated
May 18, 2022 MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metall... The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instruction... Class II DePuy Orthopaedics, Inc.
May 5, 2022 Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MW... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated
May 5, 2022 Tornado Embolization Microcoil, RPN ... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated
May 5, 2022 Nester Embolization Microcoil RPN GPN ... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated
Mar 11, 2022 VELYS Robotic-Assisted Solution Base Product No.: 451570100 System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) cha... Class II DePuy Orthopaedics, Inc.
Mar 9, 2022 RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... Potential for patient data mismatch when using browser "back" button to navigate between patients... Class II Roche Diabetes Care, Inc.
Feb 21, 2022 Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... Class II Freudenberg Medical, Llc
Feb 21, 2022 Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... Class II Freudenberg Medical, Llc
Feb 14, 2022 Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 14, 2022 BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions

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.