Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 6, 2017 | Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems | Reported incidents of a patient step detaching from the table. A fall from a patient step detach... | Class II | GE Healthcare, LLC |
| Feb 3, 2017 | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angi... | Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 3, 2017 | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Feb 3, 2017 | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); P... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Feb 3, 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... | Product recall of all HVAD Controllers currently on the market and to exchange them for the next... | Class I | Heartware |
| Feb 3, 2017 | CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Feb 2, 2017 | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Me... | The tensile strength minimum as directed by USP <881> was not met over the length of the product'... | Class II | CP Medical Inc |
| Feb 2, 2017 | Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gx... | The stopcock was found to have punctures. | Class II | Elcam Medical, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 2, 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... | Multiple software issues, which may affect the operation and workflow of the system. Potential fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 2, 2017 | Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 | The single use devices are provided sterile and do not have an expiration date on the label. | Class II | Smith & Nephew, Inc. |
| Feb 1, 2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | Class II | Nidek Inc |
| Feb 1, 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... | The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... | Class II | Respironics California Inc |
| Feb 1, 2017 | Flexor Radial Access Set, Individual product is packaged in a Tyvek-film ster... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene val... | Class II | Cook Inc. |
| Feb 1, 2017 | Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in ... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Feb 1, 2017 | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System ... | It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Trackin... | Class II | Toshiba American Medical Systems Inc |
| Feb 1, 2017 | Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Feb 1, 2017 | VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Cod... | Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. | Class II | Ortho-Clinical Diagnostics |
| Feb 1, 2017 | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-fil... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Feb 1, 2017 | Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Feb 1, 2017 | TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-f... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Feb 1, 2017 | Micropuncture Check-Flo Performer Introducer Set, Individual product is packa... | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... | Class II | Cook Inc. |
| Jan 31, 2017 | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with th... | Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adj... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 31, 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... | Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... | Class II | Medtronic Inc. |
| Jan 31, 2017 | 882478: BrightView X designed for single or dual detector nuclear imaging acc... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Ster... | Product sterility compromised due to breach of sterile barrier | Class II | Degania Silicone, Ltd. |
| Jan 31, 2017 | 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for singl... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. ... | These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820... | Class II | Synthes (USA) Products LLC |
| Jan 31, 2017 | AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 ... | Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot swi... | Class II | Boston Scientific Corporation |
| Jan 31, 2017 | 882480: BrightView designed for single or dual detector nuclear imaging accom... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 30, 2017 | Hidrex USA DP450 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx... | Labeling: The labeled storage temperature is not consistent with the temperature conditions teste... | Class II | Tearscience, Inc |
| Jan 30, 2017 | Hidrex USA DVP1000 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism... | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Jan 30, 2017 | Daavlin Aquex (DAAV1000) | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | EliA Sample Diluent, Article number, 83-1023-01 | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting... | Class II | Phadia US Inc |
| Jan 30, 2017 | A-series lift - A625 Manual Part No. 324117. Prism Medical. | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Jan 30, 2017 | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-771... | The probe misalignment or bending has the potential to lead to delay in reporting results or inco... | Class II | Beckman Coulter Inc. |
| Jan 27, 2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inse... | The wiring may allow the lamps to turn on with the key switch rather than the timer. | Class II | National Biological Corp |
| Jan 27, 2017 | VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usag... | Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the d... | Class II | Maquet Cardiovascular, LLC |
| Jan 27, 2017 | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Bl... | After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of... | Class II | Becton Dickinson & Company |
| Jan 26, 2017 | The ABL800 Model#:All | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Jan 26, 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... | SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... | Class II | Baxter Healthcare Corporation |
| Jan 26, 2017 | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Ste... | Customer reports of the device handset continuing to operate after release of the activation button. | Class II | COVIDIEN MEDTRONIC |
| Jan 26, 2017 | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures p... | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Jan 25, 2017 | MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SI... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | 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.