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 |
|---|---|---|---|---|
| Dec 9, 2025 | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name... | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Intuitive Surgical, Inc. |
| Dec 9, 2025 | Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vi... | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Intuitive Surgical, Inc. |
| Dec 9, 2025 | Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vi... | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Intuitive Surgical, Inc. |
| Dec 9, 2025 | Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: d... | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instr... | Class II | Intuitive Surgical, Inc. |
| Dec 5, 2025 | Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Numbe... | Incorrect expiration date | Class II | LimFlow, Inc. |
| Dec 4, 2025 | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | Class II | Intuitive Surgical, Inc. |
| Dec 3, 2025 | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1... | Due a software issue that may result in equipment not receiving timely updates of patient, medica... | Class II | CareFusion 303, Inc. |
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included product. | Class II | Advanced Bionics, LLC |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 20, 2025 | BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar... | Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca... | Class II | CareFusion 303, Inc. |
| Nov 17, 2025 | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used... | An error event following the release of a software version for the surgical system that can resul... | Class II | Intuitive Surgical, Inc. |
| Nov 17, 2025 | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ... | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Nov 17, 2025 | Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"... | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may r... | Class II | Sheathing Technologies Inc |
| Nov 13, 2025 | InPen App, Model/CFN Number: MMT-8061 (Android Users) | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St... | Class II | Medtronic MiniMed, Inc. |
| Nov 7, 2025 | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin... | Due to a software implementation error that allowed instruments arms failing an important diagnos... | Class II | Intuitive Surgical, Inc. |
| Nov 6, 2025 | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar... | Due to a number of modules flashed with a date and time associated with the daylight savings time... | Class II | CareFusion 303, Inc. |
| Nov 5, 2025 | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ... | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje... | Class II | Accriva Diagnostics, Inc. |
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Cepheid |
| Nov 3, 2025 | SQ40S Blood Transfusion Filter | Due to products being released for distribution prior to completion of the required quality contr... | Class II | GVS TM, Inc |
| Nov 2, 2025 | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software... | A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr... | Class II | Medtronic MiniMed, Inc. |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Oct 28, 2025 | Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: ... | An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with ... | Class II | Illumina, Inc. |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Numbe... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X1... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, i... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 ... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 21, 2025 | CareLink Clinic, REF: MMT-7350 | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... | Class II | Medtronic MiniMed, Inc. |
| Oct 21, 2025 | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415... | Due to an device without a premarket clearance being incorrectly package and distributed. | Class III | Accriva Diagnostics, Inc. |
| Oct 18, 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-B | Potential that product was leak tested with equipment outside of its expected operating range, re... | Class II | Auris Health, Inc |
| Oct 17, 2025 | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF... | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, wh... | Class I | CareFusion 303, Inc. |
| Oct 16, 2025 | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. | Affected system contains components that do not meet the required distance between electrodes for... | Class II | Canon Medical System, USA, INC. |
| Oct 13, 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | Class I | TMJ Solutions Inc |
| Oct 13, 2025 | MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE a... | Due to battery component overheating while charging resulting in melting of internal components a... | Class II | MRIMed Inc. |
| Oct 10, 2025 | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... | Acute circulatory support system pump may not fit into the motor and reports received of the pump... | Class II | Thoratec LLC |
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.