Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 30, 2022 | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, ... | There is a potential that the proximal marker may separate from the imaging catheter | Class I | Abbott Vascular |
| Mar 30, 2022 | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor block... | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are u... | Class II | Accriva Diagnostics, Inc. |
| Mar 25, 2022 | BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the An... | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 25, 2022 | BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Ant... | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 23, 2022 | TearCare version 1.0 SmartHubs | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within... | Class II | Sight Sciences, Inc. |
| Mar 23, 2022 | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 23, 2022 | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 18, 2022 | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in ... | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of de... | Class II | Hologic, Inc |
| Mar 17, 2022 | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Su... | As a result of complaint data review, it identified tissue pushout events occurring during firing... | Class II | Intuitive Surgical, Inc. |
| Mar 11, 2022 | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019... | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC... | ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ... | Class II | Total Resources Intl |
| Mar 11, 2022 | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT0... | ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ... | Class II | Total Resources Intl |
| Mar 11, 2022 | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Pl... | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 10, 2022 | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin PCS 3650 programmer Model 3330 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin 2 PCS MER3700 programmer Model MER3400 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 4, 2022 | First SIGN SARS-CoV-2 Antigen Test | Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests w... | Class II | WHPM Inc. |
| Mar 3, 2022 | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument ... | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2022 | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vin... | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... | Class II | Intuitive Surgical, Inc. |
| Mar 1, 2022 | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... | Class II | Edwards Lifesciences, LLC |
| Mar 1, 2022 | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monito... | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... | Class II | Edwards Lifesciences, LLC |
| Feb 28, 2022 | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 22, 2022 | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD | There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection... | Class II | Illumina, Inc. |
| Feb 21, 2022 | Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm | Due to failure of microbial testing for total aerobic microbial count (TAMC). | Class II | SA3, LLC |
| Feb 3, 2022 | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Nu... | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or be... | Class III | Volcano Corp |
| Jan 31, 2022 | INFX-8000V. For radiographic and fluoroscopic studies and intervention. | The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. | Class II | Canon Medical System, USA, INC. |
| Jan 27, 2022 | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... | Class II | Medtronic MiniMed |
| Jan 27, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, nar... | Excessive ultraviolet-C radiation | Class II | IN MY BATHROOM LLC |
| Jan 27, 2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusi... | Failed stability specifications for reagent kits that may result in false negative test results. | Class II | Hologic, Inc |
| Jan 24, 2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as ... | Class III | Volcano Corp |
| Jan 24, 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 24, 2022 | Philips Respironics V60 Plus Ventilator Part Number 1138747 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 20, 2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Due to a component in the hemodialysis console there is the possibility of heat-related damage th... | Class II | Outset Medical, Inc. |
| Jan 20, 2022 | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL ... | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting i... | Class II | Microgenics Corporation |
| Jan 19, 2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedura... | Class II | Volcano Corporation |
| Jan 14, 2022 | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | Optic nerve head angiography scan to be turned off due to its distribution without pre-market cle... | Class II | Carl Zeiss Meditec, Inc. |
| Jan 14, 2022 | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general l... | A software defect in the camera control unit (CCU) will cause the image on the monitor to flip up... | Class II | Stryker Corporation |
| Jan 13, 2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 10, 2022 | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
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.