Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1857-2026 | Class II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB... | Boston Scientific Corporation | DQO | |
| Z-1856-2026 | Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB... | Boston Scientific Corporation | DQO | |
| Z-1680-2026 | Class II | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1679-2026 | Class II | Azurion 5 M12; System Code: (1)722227, (2)722231; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1678-2026 | Class II | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1677-2026 | Class II | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1676-2026 | Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1675-2026 | Class II | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1674-2026 | Class II | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1673-2026 | Class II | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1672-2026 | Class II | Allura Xper FD20/15 OR Table; System Code: 722059; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1671-2026 | Class II | Allura Xper FD20/15; System Code: 722058; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1670-2026 | Class II | Allura Xper FD20/20 OR Table; System Code: 722039; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1669-2026 | Class II | Allura Xper FD20/20; System Code: 722038; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1668-2026 | Class II | Allura Xper FD20/10; System Code: 722029; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1667-2026 | Class II | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1666-2026 | Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1665-2026 | Class II | ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1664-2026 | Class II | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1663-2026 | Class II | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1662-2026 | Class II | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1661-2026 | Class II | ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1660-2026 | Class II | ALLURA Xper FD10F; System Code: 722002; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1659-2026 | Class II | Allura Xper FD10C; System Code: 722001; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1649-2026 | Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous... | Respironics, Inc. | CBK | |
| Z-1648-2026 | Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1647-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1646-2026 | Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1617-2026 | Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous... | Respironics, Inc. | CBK | |
| Z-1616-2026 | Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1615-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1614-2026 | Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use... | Respironics, Inc. | CBK | |
| Z-1738-2026 | Class II | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1737-2026 | Class II | eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1736-2026 | Class II | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1735-2026 | Class II | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1734-2026 | Class II | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1733-2026 | Class II | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1732-2026 | Class II | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-1731-2026 | Class II | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-2596-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC... | MEDLINE INDUSTRIES, LP - Northfield | OHM | |
| Z-2595-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC... | MEDLINE INDUSTRIES, LP - Northfield | MCY | |
| Z-2594-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-2593-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-2592-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-2591-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO... | MEDLINE INDUSTRIES, LP - Northfield | OEQ | |
| Z-2590-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2589-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT... | MEDLINE INDUSTRIES, LP - Northfield | FQM | |
| Z-2588-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR... | MEDLINE INDUSTRIES, LP - Northfield | KDD | |
| Z-2587-2026 | Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored... | MEDLINE INDUSTRIES, LP - Northfield | OJH |