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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
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) The device is being recalled because dynamic loading forces from larger patients can fracture the... Class II Esaote S.p.A.
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M003542... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
Jun 2, 2016 VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874... Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic P... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 2, 2016 Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Us... Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (... Class II Parker Medical
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS... Arrow is recalling these products due to the possibility that although the kit is labeled as cont... Class II Arrow International Inc
Jun 1, 2016 AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being... Class I Stryker Sustainability Solutions
Jun 1, 2016 PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoeni... BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol... Class III Becton Dickinson & Co.
Jun 1, 2016 SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid... A component of the kit is showing a sensitivity performance detected in stability testing at 15 m... Class II BBI SOLUTIONS OEM LTD
Jun 1, 2016 PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ... BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following... Class III Becton Dickinson & Co.
May 31, 2016 METS SMILES Total Knee Replacement The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the inten... Class II Stanmore Implants Worldwide Ltd.
May 31, 2016 Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 56... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwd... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor... Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and R... Class II Pentax of America Inc
May 31, 2016 Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, ... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister u... Cracks ATEC Canister Lids. Class II Hologic, Inc
May 31, 2016 Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot ... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and o... Class II Synthes (USA) Products LLC
May 31, 2016 Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope,... The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and... Class II Pentax of America Inc
May 31, 2016 Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lo... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot ... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989,... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot ... DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... Class II Synthes (USA) Products LLC
May 31, 2016 Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 ... Isolated episodes of leakage at the check valve were found Class I Draeger Medical, Inc.
May 30, 2016 Radiation Therapy Treatment Planning System, Model 5.0 For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in ... Class II RAYSEARCH LABORATORIES AB

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.