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 |
|---|---|---|---|---|
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 21, 2019 | Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 19, 2019 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... | It was reported that the user's low alarm feature on the iOS application were not properly alert... | Class II | Dexcom Inc |
| Nov 18, 2019 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 ... | Registering dose and structures in the treatment delivery workflow could result in an alignment d... | Class II | Viewray, Inc. |
| Nov 14, 2019 | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromoge... | False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (AT... | Class II | Hardy Diagnostics |
| Nov 14, 2019 | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938... | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... | Class II | Abbott Diabetes Care, Inc. |
| Nov 14, 2019 | Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... | Class II | Abbott Diabetes Care, Inc. |
| Nov 14, 2019 | Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,... | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... | Class II | Abbott Diabetes Care, Inc. |
| Nov 7, 2019 | iChem VELOCITY Urine Chemistry Analyzer | Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for th... | Class II | Beckman Coulter Inc. |
| Nov 6, 2019 | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitati... | The chemiluminescent immunoassay has been noted to have higher than expected results which may re... | Class II | Qualigen Inc |
| Nov 6, 2019 | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 4, 2019 | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained ... | The DAP meters were found to be outside of tolerance. | Class II | Shimadzu Medical Systems |
| Oct 30, 2019 | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ;... | Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be pr... | Class II | Allergan PLC |
| Oct 28, 2019 | iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375,... | Customers have reported incidents where two sets of results report the same Specimen Identifier (... | Class II | Beckman Coulter Inc. |
| Oct 28, 2019 | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-71... | Customers have reported incidents where two sets of results report the same Specimen Identifier (... | Class II | Beckman Coulter Inc. |
| Oct 24, 2019 | Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 24, 2019 | Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 24, 2019 | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 23, 2019 | GENTLEWAVE REF: FG-002-0001 | The console would continue to run for extended period when the foot pedal was released. | Class II | Sonendo Inc |
| Oct 22, 2019 | EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vente... | Their is a possibility that the cannula may separate from its connector, potentially causing a br... | Class II | Edwards Lifesciences, LLC |
| Oct 21, 2019 | MicroScan WalkAway-96 plus Instrument REF B1018-284 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | DxM 1040 MicroScan WalkAway Instrument REF B1018-440 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | DxM 1096 MicroScan WalkAway Instrument REF B1018-496 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-40 plus Instrument REF B1018-283 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 18, 2019 | CapsoCAM Plus, UDI: 00867770000209 | Capsule Endoscopy System: a defect present in the capsule window may be stressed through the prod... | Class II | Capso Vision, Inc. |
| Oct 14, 2019 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... | Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... | Class II | Mizuho OSI |
| Oct 11, 2019 | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two ... | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO s... | Class II | Nucryo Vascular Inc. |
| Oct 11, 2019 | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, S... | Through a customer complaint and and internal investigation it was determined that some implant p... | Class II | Implant Direct Sybron Manufacturing LLC |
| Oct 10, 2019 | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase... | Firm has identified product has no staining. If used, may result in invalid test results when use... | Class II | Biocare Medical, LLC |
| Oct 10, 2019 | Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisti... | Reagent component included in flu test kit may cause both high background signal in a true negati... | Class II | Hologic, Inc |
| Oct 7, 2019 | Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usag... | Intermittent communication due to inconsistent crimping of connectors onto cables. | Class II | Edwards Lifesciences, LLC |
| Oct 7, 2019 | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue... | Walkers within the identified serial range have the potential for the front fork to unscrew itsel... | Class II | Nova Ortho-Med Inc |
| Oct 7, 2019 | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Oct 4, 2019 | REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-w... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, 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.