Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 27, 2022 | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil Syst... | Due to incorrect size and configuration labeling of the detachable coil system. | Class II | Micro Therapeutics, Inc. |
| Apr 7, 2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reor... | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Mod... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 6, 2022 | Accula SARS-CoV-2 Test, REF: COV4100 | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay ... | Class I | MESA BIOTECH, INC |
| Apr 6, 2022 | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, | Potential breach in the sterility barrier for tray ring covers. | Class II | Johnson & Johnson Surgical Vision Inc |
| Apr 1, 2022 | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VA... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/20... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF ... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A F... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| 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 |
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.