Browse Device Recalls

4,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,653 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 4,653 FDA device recalls in CA.

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DateProductReasonClassFirm
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... Class II Intuitive Surgical, Inc.
Apr 23, 2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class II SSC- Surgical Specialties Corporation
Apr 22, 2026 Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... Class II Boston Scientific Neuromodulation Corporation
Apr 22, 2026 Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... Class II Intuitive Surgical, Inc.
Apr 21, 2026 Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... Class II PFM MEDICAL INC.
Apr 20, 2026 Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... Electromagnetic contactors within high voltage generator may weld together, resulting in current ... Class II Shimadzu Medical Systems
Apr 14, 2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 9, 2026 Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... Due to nonconforming products being inadvertently distributed. Class II Stryker Corporation
Apr 8, 2026 Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Pacing Catheter, Models: D200F7; Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 6, 2026 INZONE DETACHMENT SYSTEM, REF: M00345100950 Embolization coil detachment system devices may experience premature battery drain causing device... Class II Stryker Neurovascular
Apr 6, 2026 QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, strepto... Product has the potential for false positive results Class II Quidel Corporation
Apr 6, 2026 LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xW... Stent-assisted coiling device may due to commingling during manufacturing have dimensional noncon... Class II MICROVENTION INC.
Apr 2, 2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to break... Class II Intuitive Surgical, Inc.
Mar 27, 2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Labeling update to provide warning if functionality of the valve replacement delivery system is ... Class II Edwards Lifesciences, LLC
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.

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.