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 24, 2026 | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, ... | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy de... | Class II | ICU Medical, Inc. |
| Mar 23, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery P... | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-... | Class II | Advanced Bionics, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: ... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 12, 2026 | iLet Bionic Pancreas, REF: BB1001 | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring ... | Class II | Beta Bionics, Inc. |
| Mar 11, 2026 | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48... | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Class I | Intuitive Surgical, Inc. |
| Feb 20, 2026 | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly d... | Class II | Masimo Corporation |
| Feb 20, 2026 | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly d... | Class II | Masimo Corporation |
| Feb 18, 2026 | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog N... | Due to product exhibiting potential to generate either invalid or false negative results. | Class II | Hologic, Inc. |
| Feb 13, 2026 | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 530G Insulin Pump (MMT-551, MMT-751) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm Insulin Pump (MMT-712, MMT-715) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 620G Insulin Pump (MMT-1750) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 11, 2026 | TMJ Bilateral Implants, REF: CHG020 | Custom temporomandibular joint implant may have contained incorrect patient-specific components t... | Class II | TMJ Solutions Inc |
| Feb 11, 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... | Class II | CareFusion 303, Inc. |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 componen... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
| Feb 9, 2026 | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... | Class II | Reflexion Medical, Inc. |
| Jan 30, 2026 | Tandem pumps are battery-operated infusion pumps capable of both basal and bo... | The Czech language user guide contained multiple translation errors. The most significant error ... | Class II | Tandem Diabetes Care, Inc. |
| Jan 30, 2026 | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... | Class II | Medtronic MiniMed, Inc. |
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Class II | ReCor Medical Inc. |
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Class II | ReCor Medical Inc. |
| Jan 21, 2026 | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet... | Class II | Stryker Corporation |
| Jan 21, 2026 | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-0... | Device for bronchoscopic visualization, patient airway access has software issue: if application ... | Class II | Auris Health, Inc |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Dec 30, 2025 | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Nu... | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may resu... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2025 | Alphenix INFX-8000C, interventional fluoroscopic x-ray system | It has been discovered that there is a possibility that the fixing screws of the ceiling movement... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Alphenix INFX-8000V, interventional fluoroscopic x-ray system | It has been discovered that there is a possibility that the fixing screws of the ceiling movement... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Alphenix INFX-8000H, interventional fluoroscopic x-ray system | It has been discovered that there is a possibility that the fixing screws of the ceiling movement... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Alphenix INFX-8000F, interventional fluoroscopic x-ray system | It has been discovered that there is a possibility that the fixing screws of the ceiling movement... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R... | Needle free access device intended as accessory to vascular access used in hemodialysis or access... | Class II | ICU Medical, Inc. |
| Dec 19, 2025 | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 15, 2025 | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ... | Access Port System tray may develop cracks potentially resulting in a sterility breach. | Class II | Intuitive Surgical, Inc. |
| Dec 11, 2025 | Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 | There is the potential for extended length of the blade obturator after assembly into the cannula... | Class II | Applied Medical Resources Corp |
| Dec 9, 2025 | Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vin... | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instr... | Class II | Intuitive Surgical, Inc. |
| Dec 9, 2025 | Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Nam... | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Intuitive Surgical, 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.