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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

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Clear
DateProductReasonClassFirm
May 14, 2013 StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion D... A component Superior endplate manufactured from a different polymer than specified Class II Spine Wave, Inc.
May 13, 2013 NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm he... During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the ... Class II Collagen Matrix Inc
May 13, 2013 ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack ... Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (EC... Class II Ethicon Endo-Surgery Inc
May 13, 2013 Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of... Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2... Class II Coloplast Manufacturing US, LLC
May 13, 2013 HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer ... Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. Class II Life Technologies Corporation
May 13, 2013 Siemens AXIOM Artis zeego x-ray, angiographic system Siemens issued a customer safety notice about the overlay of system information after a functiona... Class II Siemens Medical Solutions USA, Inc
May 13, 2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Pr... It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TB... Class II Microgenics Corporation
May 13, 2013 Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 107984... Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports... Class I Endologix Inc
May 10, 2013 IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitative... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, 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 Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intende... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely conso... Under certain conditions the system may not perform as intended, causing the release of results t... Class II Siemens Healthcare Diagnostics, Inc.
May 10, 2013 ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
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 Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, 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 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 ... MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to ... Class II ErgoSafe Product LLC dba Prism Medical Services
May 10, 2013 Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (... A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, LLC
May 10, 2013 Responder 5 is a nurse call communication system that connects patients with ... A counterfeited electronic component was identified in the products affected. The component, a da... Class II Rauland-Borg Corp
May 10, 2013 IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
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 10, 2013 Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conju... Device design. Class II SpineFrontier, Inc.
May 9, 2013 NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by... Potential for images to be flipped while streaming, which could incorrectly display image orienta... Class II Novarad Corporation
May 9, 2013 Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcan... As a result of the investigation into an adverse trend of complaints for reports of misalignment ... Class II Integra LifeSciences Corporation
May 9, 2013 GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... GE Healthcare has recently become aware of a potential safety issue with respect to the automated... Class II GE Healthcare, LLC
May 9, 2013 Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. T... An inconsistency was identified related to electronic display identification of the optional Mult... Class II ConBio, a CynoSure Company
May 9, 2013 VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number... While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant ... Class III Ortho-Clinical Diagnostics
May 9, 2013 VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 a... While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amou... Class III Ortho-Clinical Diagnostics
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 8, 2013 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distri... Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors ver... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgic... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and... Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of p... Class I Verathon, Inc.
May 8, 2013 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 7, 2013 MEDITECH Bi-Directional interactive Communication Analyzer Interface; Int... Incorrect transmission of laboratory results. Class II Medical Information Technology, Inc.
May 7, 2013 Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-ste... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical Inc
May 7, 2013 Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system Siemens became aware of an unintended behavior when using the Luminos dRF with software version V... Class II Siemens Medical Solutions USA, Inc
May 7, 2013 InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Us... Potential for set screw to be come deformed. Class II SpineFrontier, Inc.
May 7, 2013 The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafti... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical Inc
May 7, 2013 Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile gr... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical Inc
May 6, 2013 Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with sof... Siemens has discovered through product monitoring a potential malfunction when using system opera... Class II Siemens Medical Solutions USA, 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.