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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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Nov 29, 2022 OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For... Product missing the four small locking collar bolts resulting in extension of surgery to find a r... Class II Biomet, Inc.
Sep 12, 2022 Orthex Large Bone Shoulder Bolt, model no. AS-17 Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with fram... Class II OrthoPediatrics Corp
Aug 25, 2022 G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 ... The outer sterile package cavity has a corner wall thickness that is below the specification. The... Class II Zimmer, Inc.
Aug 16, 2022 Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; 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 Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS... 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 (Straight), Guidewire Reference Part Number/GPN: C-SF... 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 (Nimble Floppy), Guidewire RFPC-35-145 G07914 Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 PTS Panels CHOL+GLU Test Strips (REF 1765) Incorrect instructions for use were packaged into the final product. Class III Polymer Technology Systems, Inc. dba PTS Diagno...
Aug 16, 2022 Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... 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, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
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.

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.