Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 14, 2020 | Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For ... | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 14, 2020 | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Pa... | There is a software issue which may result in failure to monitor or control patient's bed exit me... | Class II | Hill-Rom Inc. |
| Feb 14, 2020 | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 1109... | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibratio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 14, 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Ar... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... | Firm identified software issues which leads to the patient ID and patient information not being s... | Class II | ICU Medical, Inc. |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 13, 2020 | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determinatio... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral ... | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... | Class II | Merit Medical Systems, Inc. |
| Feb 13, 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product ... | Post-implantation separation of an actuator end cap component that may expose internal components... | Class II | NuVasive Inc |
| Feb 13, 2020 | DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Verte... | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... | Class II | Merit Medical Systems, Inc. |
| Feb 13, 2020 | Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnost... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (7... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for th... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (... | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 13, 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated power... | Due to programming errors in the Controller, an increase in the set motor parameters can be made ... | Class II | Sunrise Medical (US) LLC |
| Feb 13, 2020 | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D... | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blo... | Class II | Insulet Corporation |
| Feb 12, 2020 | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Feb 12, 2020 | Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 12, 2020 | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Feb 12, 2020 | Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:Th... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 12, 2020 | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... | Proximal end of the driver in the affected product may be oversized in varying degrees, potentia... | Class II | Nextremity Solutions |
| Feb 11, 2020 | NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use | The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU... | Class II | MARVAO MEDICAL DEVICES LTD. |
| Feb 11, 2020 | NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging | Class II | Nelson Innovaions, Llc |
| Feb 11, 2020 | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - P... | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. | Class II | Intellijoint Surgical, Inc. |
| Feb 11, 2020 | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Feb 11, 2020 | Imager II 5F Angiographic Catheters, 5 units per package. | Potential for tip detachment of Imager II 5F Angiographic Catheters | Class I | Boston Scientific Corporation |
| Feb 10, 2020 | Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and F... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 10, 2020 | Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and... | Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 10, 2020 | Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray ... | The Ysio system may process incorrect internal values for the position of its ceiling tube stand.... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 10, 2020 | Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed ... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 10, 2020 | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomograph... | Tomosynthesis image acquisition sequence did not stop automatically after expected number of expo... | Class II | Agfa N.V. |
| Feb 10, 2020 | SPICE (JWH-018) CC443 | Corrections are being made to the device labeling regarding its intended use, to include a statem... | Class II | Carolina Liquid Chemistries Corp |
| Feb 10, 2020 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Feb 7, 2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U... | Nonconforming product which was dispositioned for rejection was mistakenly released for commercia... | Class III | Integra LifeSciences Corp. |
| Feb 7, 2020 | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immu... | The firm has received an increased number of complaints concerning non-reproducible elevated resu... | Class II | Roche Diagnostics Operations, Inc. |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included... | The sterile packaging has the potential to be compromised. | Class II | Deroyal Industries, Inc. Lafollette |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. | Class II | Invivo Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 5, 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system con... | The top seal of some of the pouches was compromised which can allow moisture to enter that can im... | Class II | bioMerieux, 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.