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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
Jun 7, 2013 REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
May 30, 2013 TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complet... When the bed is put into the chair egress position, the magnets on the mattress may not hold the... Class II Hill-Rom, Inc.
May 23, 2013 Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00... This is a recall expansion from the 2010 recall which now includes seven additional lots that wer... Class II Zimmer, Inc.
May 23, 2013 Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 430... This is a recall expansion from the 2010 recall which now includes seven additional lots that wer... Class II Zimmer, Inc.
May 16, 2013 CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by p... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 CoaguChek XS Plus System The CoaguChek XS Plus system for use by professio... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the ... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro mete... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 15, 2013 Superior Approach Resection Guide Assembly. Indicated for primary, fractur... Biomet has initiated this action following an investigation which identified that the slot on the... Class II Biomet, Inc.
May 10, 2013 Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr )... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOL... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,..... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(15... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/si... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2m... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 8, 2013 DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... Class III DePuy Orthopaedics, Inc.
May 3, 2013 DePuy Glenosphere orientation guide Product Usage: The glenosphere o... The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being ... Class II DePuy Orthopaedics, Inc.
Apr 30, 2013 SlingBar Wide 670. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar 360. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar Standard. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar 350. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 29, 2013 Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Syst... Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which invo... Class II Biomet, Inc.
Apr 26, 2013 Active Articulation E1. Intended for use with either primary or revision h... Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this actio... Class II Biomet, Inc.
Apr 25, 2013 B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoass... Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interferen... Class II Roche Diagnostics Operations, Inc.
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 18, 2013 Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile ... Cook Medical has received a small number of complaints related to the delivery system for the Zil... Class I Cook, Inc.
Apr 18, 2013 Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile... Cook Medical has received a small number of complaints related to the delivery system for the Zil... Class I Cook, Inc.
Apr 15, 2013 Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for... Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or ... Class II Hill-Rom, Inc.
Apr 4, 2013 Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, im... When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain ass... Class II Roche Diagnostics Operations, Inc.
Apr 4, 2013 PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Pr... Internal investigation demonstrated under-recovery for glucose when tested against a reference me... Class II Polymer Technology Systems, Inc.
Mar 27, 2013 NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. U... Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the p... Class II Zimmer, Inc.
Mar 6, 2013 ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Use... Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode... Class II Roche Diagnostics Operations, Inc.
Mar 6, 2013 CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used... Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode... Class II Roche Diagnostics Operations, Inc.
Mar 1, 2013 Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog n... Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir... Class II Roche Diagnostics Operations, Inc.
Feb 26, 2013 TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered ... In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead... Class II Hill-Rom, Inc.
Feb 25, 2013 ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular... The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to ... Class II DePuy Orthopaedics, Inc.
Feb 25, 2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... Class I Symbios Medical Products, LLC
Feb 14, 2013 Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter ass... The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting b... Class II Zimmer, Inc.
Feb 10, 2013 ROSA Surgical Device 2.5.8 Issue with optional neuro-endoscopy module detected under specific conditions during internal tes... Class II Zimmer Biomet, Inc.
Feb 8, 2013 Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... Class II Zimmer, Inc.
Feb 5, 2013 Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma ... Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance... Class II DePuy Orthopaedics, Inc.
Feb 5, 2013 REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Ortho... The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of... Class II Biomet, Inc.
Feb 5, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... Observed instability of the device. Class II Zimmer 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.