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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

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Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Sep 27, 2016 Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 Th... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH,... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN.... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 Th... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Di... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEE... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubin... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Tr... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 26, 2016 Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is int... Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during ... Class II Hamilton Medical, Inc.
Sep 25, 2016 FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch"... The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a full... Class II Lumenis Limited
Sep 25, 2016 Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the di... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Sep 24, 2016 BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provid... Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential ... Class II Surgical Specialties Mexico S DE RL DE CV
Sep 23, 2016 OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Produc... GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 6... Class II GE OEC Medical Systems, Inc
Sep 23, 2016 Fluid Management Set. Catalog Number K08-MP5159A Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Waste Management Kit. Catalog Number K10-04381AP Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Manifold Kit. Catalog Number K09-11867AP Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario... Potential risk associated with corrosion demonstrated on the distraction screw surface. Class II Cardinal Health 200, LLC
Sep 23, 2016 Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The V... Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the... Class II Sequent Medical Inc
Sep 22, 2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product ... There is a potential for a component failure of the device which could necessitate medical interv... Class II AtriCure, Inc.
Sep 22, 2016 COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA ... Due to product design and process control, part of the device can separate and remain behind when... Class II AtriCure, Inc.
Sep 22, 2016 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate... Class II Medtronic Navigation, Inc.-Littleton
Sep 21, 2016 CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody r... CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity Class II Becton, Dickinson and Company, BD Biosciences
Sep 20, 2016 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... Sterility of syringe product could not be assured. Class II Custom Medical Specialties, Inc.
Sep 19, 2016 VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporizat... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. T... Product was found to contain excess residual levels of hydrogen peroxide. Class II Bausch & Lomb Inc Irb
Sep 19, 2016 Empowr PS Knee System Box Cut Guide; Used to make the housing resection for ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or... Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devi... Class II Stryker Sustainability Solutions
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GH... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Aequalis Fx2 implant parts and instrument trays. Insert component : Part ... Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to repo... Class II Tornier, Inc
Sep 19, 2016 CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermato... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 19, 2016 Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Sep 19, 2016 ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, exc... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 16, 2016 12C IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... Class II Ion Beam Applications S.A.
Sep 16, 2016 RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm... RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ ... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...

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.