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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

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.

Clear
DateProductReasonClassFirm
Feb 17, 2016 TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO... The firm received a complaint of an open pouch which breaches the sterilization validation. Class II Applied Medical Technology Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arr... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile E... The firm received a complaint of an open pouch which breaches the sterilization validation. Class II Applied Medical Technology Inc
Feb 17, 2016 GE Healthcare, Aisys CS2 anesthesia.. GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... Class II GE Medical Systems, LLC
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous acce... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An a... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Universal aluminum crutch, 1 pair per case Aid the user in walking while r... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walk... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 16, 2016 Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac... Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract... Class II Biomet, Inc.
Feb 16, 2016 Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For us... Multiple complaints were received from customers indicating that they ordered product 8335(Type 3... Class III Richard-Allan Scientific Company
Feb 16, 2016 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guid... DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking... Class II Synthes (USA) Products LLC
Feb 16, 2016 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 HipLOC CHS Plate/Lag Screw Introducer A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not... Class II Biomet, Inc.
Feb 16, 2016 Automated peritoneal dialysis (APD) cycler Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructi... Class II Baxter Healthcare Corp.
Feb 16, 2016 CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: Th... Siemens found a defective part in their production line which could increase risk of an electrica... Class II Siemens Medical Solutions USA, Inc
Feb 16, 2016 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touch... Class II Intuitive Surgical, Inc.
Feb 16, 2016 VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & ... The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situ... Class II Ortho-Clinical Diagnostics
Feb 16, 2016 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 Milex Arcing Diaphragm Size 95; Model Number: MXWS95 The products have been identified to contain an incorrect size Diaphragm. Class II CooperSurgical, Inc.
Feb 16, 2016 Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN m... Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots... Class II Siemens Healthcare Diagnostics, Inc.
Feb 16, 2016 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages a... Class II CareFusion 303, Inc.
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2016 Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) fo... Decreasing performance overtime. Class II Euro Diagnostica AB
Feb 12, 2016 Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... Complaints were received claiming the material failed to polymerize under the curing light. Afte... Class II Ivoclar Vivadent, Inc.
Feb 12, 2016 10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Mod... Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mi... Class II Biomet Spine, LLC
Feb 12, 2016 Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca... Class II CareFusion 303, Inc.
Feb 12, 2016 Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stab... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 12, 2016 Mammomat Inspiration with Tomosynthesis functionality A potential system fatal error may occur during tomosynthesis reconstruction with large breasts t... Class II Siemens Medical Solutions USA, Inc
Feb 12, 2016 BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, ... BD has confirmed that a portion of BD SurePath" collection vials associated with specific product... Class II Becton Dickinson & Co.
Feb 12, 2016 Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or mo... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 11, 2016 MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 ... Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software... Class II Beckman Coulter Inc.
Feb 11, 2016 USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Di... Product may kink during use rendering the product unusable. Class II Us Endovascular
Feb 11, 2016 KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) ... AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. Class II AcuFocus, Inc.
Feb 11, 2016 Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Gluc... Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss... Class II Roche Diagnostics Operations, Inc.
Feb 11, 2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... 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.