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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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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
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 8, 2016 SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an optio... Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. Thi... Class II DePuy Orthopaedics, Inc.
Jan 8, 2016 Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localizati... Product potentially exposed to body fluids during processing. Potential adverse events that may ... Class II Cook Inc.
Jan 6, 2016 Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Single Lumen Central Venous Catheter Sets and Trays The subject sets and t... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject set... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Dec 22, 2015 Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Manufacturing of the joint between the inner catheter and stylet of the delivery system does not ... Class II Cook Medical Incorporated
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Dec 2, 2015 Green Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Dec 2, 2015 Black Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Nov 24, 2015 Persona EM Proximal Tube, orthopedic manual surgical instrument for use with ... Complaints that the ratchet teeth of the tube are not latching onto the rod. Class II Zimmer, Inc.
Nov 24, 2015 Persona EM Distal Rod, orthopedic manual surgical instrument for use with Per... Complaints that the ratchet teeth of the tube are not latching onto the rod. Class II Zimmer, Inc.
Nov 20, 2015 A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization ... These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in th... Class II Biomet, Inc.
Nov 19, 2015 VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... Class II Cook Inc.
Nov 17, 2015 Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a post... Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through prod... Class II Zimmer Biomet, Inc.
Nov 17, 2015 Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), ... PMMA is listed as a material on the label but the product does not contain PMMA. Class II Biomet, Inc.
Nov 10, 2015 Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trig... The firm identified a malfunction which made it possible for a handpiece to start by itself when ... Class II Zimmer, Inc.
Nov 10, 2015 UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5... Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured in... Class II OrthoPediatrics Corp
Nov 10, 2015 Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trig... The firm identified a malfunction which made it possible for a handpiece to start by itself when ... Class II Zimmer, Inc.
Oct 29, 2015 Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device Th... A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolv... Class II Zimmer Biomet, Inc.
Oct 21, 2015 Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight c... Cook Medical has received six product complaints associated with reports of the 2.6FR curved cath... Class II Cook Inc.
Oct 7, 2015 Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angi... Reports of catheter tip splits and or separation. Loss of device function, medical intervention t... Class I Cook Inc.
Oct 7, 2015 Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury wh... Class II Hill-Rom, Inc.
Sep 22, 2015 Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that i... Possible for sample tubes in the loader to be opened and contaminate the system as well as adjace... Class II Roche Diagnostics Operations, Inc.
Sep 11, 2015 One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Bu... Class II Boston Scientific Corp
Sep 8, 2015 Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The S... DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Int... Class II DePuy Orthopaedics, Inc.
Sep 3, 2015 Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC s... under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack c... Class II Roche Diagnostics Operations, Inc.
Aug 27, 2015 Zimmer Guide Wires for orthopedic procedures. Product labeling of these sterile guide wires (external carton label and patient record label) st... Class II Zimmer, Inc.
Aug 11, 2015 Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrume... It was found through review of open Complaints and stock investigations that a single lot of Zimm... Class II Zimmer, Inc.
Jul 29, 2015 NICO Myriad Console Model number NN-7000 The Myriad System is a surgical... Two cables within the console were inadvertently twisted during manufacturing. The individual wir... Class II Nico Corp.
Jul 28, 2015 Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. The device was assembled without screw hole plugs. Class II Biomet, Inc.
Jul 28, 2015 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part nu... The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a d... Class II OrthoPediatrics Corp
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 2, 2015 Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use i... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiog... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. ... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jun 24, 2015 S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood ... The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to ... Class II Roche Diagnostics Operations, Inc.
Jun 22, 2015 Contour Next Control Solution for Contour Next Blood Glucose Test System. Li... If the control solution bottle is not thoroughly shaken prior to use, the control test result may... Class II Bayer Healthcare, LLC
Jun 17, 2015 A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surg... Class II Biomet, 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.