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 |
|---|---|---|---|---|
| Apr 30, 2026 | BD Pyxis MedStation ES Tower REF: 352 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation ES REF: 323 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... | Due to incorrect shelf-life expiration date. | Class II | Advanced Bionics, LLC |
| Apr 30, 2026 | BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis Mini Main REF: 349 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| 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 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 | 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 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 | 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. |
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.