Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 14, 2014 | Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard S... | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the c... | Class II | Merit Medical Systems, Inc. |
| Apr 14, 2014 | TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), ... | The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that... | Class II | Tenex Health Inc |
| Apr 14, 2014 | Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product ... | Grasper jaw may break when force is applied to the jaw | Class II | Microline Surgical |
| Apr 14, 2014 | Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor ... | A small number of Vista Air Compressors were miswired, which if installed and powered up, could c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 14, 2014 | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, sin... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Mete... | Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneous... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 14, 2014 | Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, sing... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The access... | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large ... | Class II | Ivoclar Vivadent, Inc. |
| Apr 11, 2014 | AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a... | It was determined that under rare environmental conditions (i.e., extremely dry air in combinatio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2014 | NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, N... | Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used ... | Class II | Blue Belt Technologies MN |
| Apr 10, 2014 | Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-... | Naturalyte Liquid Bicarbonate maybe contaminated | Class I | Fresenius Medical Care Holdings, Inc. |
| Apr 10, 2014 | ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. ... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemen... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The c... | One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result... | Class II | Synthes, Inc. |
| Apr 10, 2014 | ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 103... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in v... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 0649... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vit... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021.... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vit... | Software anomaly: potential for delay in the reporting of patient sample test results when using ... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 1069920... | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 10, 2014 | VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | Class II | Ortho-Clinical Diagnostics |
| Apr 9, 2014 | Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo C... | Potential for separation of dilator tips. | Class II | Edwards Lifesciences, LLC |
| Apr 9, 2014 | Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure th... | Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imper... | Class II | Cochlear Americas Inc. |
| Apr 9, 2014 | GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: ... | When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmi... | Class II | GE Healthcare, LLC |
| Apr 9, 2014 | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... | Class II | Ev3, Inc. |
| Apr 9, 2014 | Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial can... | Potential for separation of dilator tips. | Class II | Edwards Lifesciences, LLC |
| Apr 8, 2014 | Intended for both adult and pediatric patients for taking diagnostic radiogra... | In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an un... | Class II | Philips Medical Systems, Inc. |
| Apr 8, 2014 | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) ... | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Cal... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 8, 2014 | MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 Micro... | Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged wi... | Class II | Beckman Coulter, Inc. |
| Apr 8, 2014 | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Sy... | Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the inc... | Class II | Synthes, Inc. |
| Apr 8, 2014 | e.cam -emission computed tomography system Used to detect or image the dis... | There is a potential for patient finger injury on the e.cam systems. | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 7, 2014 | Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite... | Package inserts have incorrect SmartWash parameters for Triglyceride. | Class II | Abbott Laboratories, Inc |
| Apr 7, 2014 | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebr... | The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a compo... | Class III | Laurimed LLC |
| Apr 7, 2014 | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination... | JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to cer... | Class II | JAS Diagnostics Inc. |
| Apr 7, 2014 | GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 ... | GE Healthcare has recently become aware of a potential safety issue due to higher than actual flo... | Class II | GE Healthcare, LLC |
| Apr 7, 2014 | Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. | Class II | Western / Scott Fetzer Company |
| Apr 7, 2014 | SBi RingFix Olive Wires Product Usage: These are temporary devices indica... | Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-30... | Class II | Small Bone Innovations, Inc. |
| Apr 4, 2014 | Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... | Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present i... | Class II | BD Biosciences, Systems & Reagents |
| Apr 4, 2014 | Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor... | The risk of battery failure increases with age, when a battery remains in use longer than 3 years... | Class II | Philips Medical Systems, Inc. |
| Apr 4, 2014 | Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harm... | Potential for the welded seam in affected monitor spring arms to crack and/or break. | Class II | Steris Corporation |
| Apr 4, 2014 | TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Apr 4, 2014 | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) RE... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Apr 4, 2014 | Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... | Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... | Class II | Medtronic Neuromodulation |
| Apr 3, 2014 | syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication... | A complaint reported that the archiving method at one customer site was changed from implicit to ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 3, 2014 | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... | Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... | Class II | Baxter Healthcare Corp. |
| Apr 3, 2014 | Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Contin... | There is a potential safety risk associated with potentially damaged locking pins within the brac... | Class II | Bayer Corp |
| Apr 3, 2014 | iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... | Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... | Class II | Boston Scientific Corporation |
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.