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 |
|---|---|---|---|---|
| Apr 8, 2025 | Artix MT Thrombectomy Device, REF: 32-102 | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for... | Class II | Inari Medical - Oak Canyon |
| Apr 2, 2025 | Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... | Due to manufacturing issues, abutment products were manufactured with screw seat located too high... | Class II | Preat Corp |
| Mar 20, 2025 | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... | Class II | Agilent Technologies, Inc. |
| Mar 20, 2025 | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the b... | Class II | Channel Medsystems, Inc. |
| Mar 20, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... | Class II | Beckman Coulter Inc. |
| Mar 17, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | The reason for the recall is incorrect sample barcode identification and processing errors that r... | Class II | Beckman Coulter Inc. |
| Mar 13, 2025 | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... | Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau... | Class I | Thoratec LLC |
| Mar 11, 2025 | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... | Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie... | Class II | CareFusion 303, Inc. |
| Mar 5, 2025 | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... | Class II | Advanced Bionics, LLC |
| Mar 4, 2025 | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre... | Class I | ZOLL Circulation, Inc. |
| Mar 4, 2025 | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... | Insulin pens may have been incorrectly assembled therefore users could experience the following: ... | Class II | Medtronic MiniMed, Inc. |
| Feb 27, 2025 | Tandem Mobi Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 27, 2025 | t:slim X2 Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 26, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... | Class II | Beckman Coulter Inc. |
| Feb 26, 2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu... | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara... | Class I | Qapel Medical Inc. |
| Feb 26, 2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped... | Class II | Intuitive Surgical, Inc. |
| Feb 24, 2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... | Class II | PYRAMES INC |
| Feb 19, 2025 | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended fo... | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to ... | Class I | Calyxo, Inc. |
| Feb 18, 2025 | BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p... | Class I | CareFusion 303, Inc. |
| Feb 18, 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p... | Class I | CareFusion 303, Inc. |
| Feb 15, 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... | Class II | Abbott Medical |
| Feb 6, 2025 | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... | Sync timeout may occur between the server and automated dispensing device, due to a server softwa... | Class II | CareFusion 303, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-754 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 620G (MMT-1750) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm REF: MMT-712 and MMT-715 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 30, 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... | Class I | Micro Therapeutics, Inc. |
| Jan 30, 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... | Class I | Micro Therapeutics, Inc. |
| Jan 29, 2025 | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643... | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire rema... | Class II | Stryker Corporation |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001... | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 23, 2025 | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The B... | Due to fingerprint scanner failing resulting in the scanner heating up. | Class II | CareFusion 303, Inc. |
| Jan 23, 2025 | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite ... | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in th... | Class II | CareFusion 303, Inc. |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling around manual access... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, 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.