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-1873-2021 | Class II | Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile... | Medtronic Perfusion Systems | DWF | |
| Z-1872-2021 | Class II | Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1869-2021 | Class II | HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for... | Medtronic, Inc. | CAH | |
| Z-1868-2021 | Class II | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated... | Medtronic, Inc. | CAH | |
| Z-1867-2021 | Class II | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage... | Medtronic, Inc. | CAH | |
| Z-1866-2021 | Class II | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single... | Medtronic, Inc. | CAH | |
| Z-1871-2021 | Class II | Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-2013-2021 | Class II | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R | Randox Laboratories, Limited | CEM | |
| Z-1976-2021 | Class II | Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For... | Medtronic, Inc. | MIH | |
| Z-2090-2021 | Class II | 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius... | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | |
| Z-2089-2021 | Class II | The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that... | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | |
| Z-2088-2021 | Class II | The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a... | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | |
| Z-2087-2021 | Class II | NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-2086-2021 | Class II | Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-2085-2021 | Class II | 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage... | Fresenius Medical Care Renal Therapies Group, LLC | FKX | |
| Z-2084-2021 | Class II | Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-2083-2021 | Class II | The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used... | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | |
| Z-2082-2021 | Class II | (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-1862-2021 | Class II | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO)... | Circulatory Technology, Inc. | DTN | |
| Z-1928-2021 | Class I | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | Ortho-Clinical Diagnostics, Inc. | QJR | |
| Z-1844-2021 | Class II | Quanta System Sterile Optical Laser Fiber, reusable | Quanta System Inc. | GEX | |
| Z-1797-2021 | Class II | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit... | Medtronic Sofamor Danek USA Inc | MRW | |
| Z-1843-2021 | Class II | Quanta System Sterile Optical Laser Fiber, single use | Quanta System Inc. | GEX | |
| Z-1842-2021 | Class II | Olympus Sterile Optical Laser Fiber, single use and reusable | Quanta System Inc. | GEX | |
| Z-0174-2022 | Class II | Concerto User Interface Software provided with the following systems: (1) Xstrahl 100... | Xstrahl Limited | JAD | |
| Z-2334-2021 | Class II | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of... | Northeast Scientific Inc. | OWQ | |
| Z-1827-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1826-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1825-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1824-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1823-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1822-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1821-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1820-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1819-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1818-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1817-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1816-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1815-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1814-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1813-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1812-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1811-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1810-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1809-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1808-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1807-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm... | Alphatec Spine, Inc. | KWQ | |
| Z-1806-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24... | Alphatec Spine, Inc. | KWQ | |
| Z-1805-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22... | Alphatec Spine, Inc. | KWQ | |
| Z-1804-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21... | Alphatec Spine, Inc. | KWQ |