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-1803-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20... | Alphatec Spine, Inc. | KWQ | |
| Z-1802-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19... | Alphatec Spine, Inc. | KWQ | |
| Z-1801-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18... | Alphatec Spine, Inc. | KWQ | |
| Z-1800-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17... | Alphatec Spine, Inc. | KWQ | |
| Z-1799-2021 | Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16... | Alphatec Spine, Inc. | KWQ | |
| Z-1779-2021 | Class II | REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. | Meta C.G.M. SpA | EMI | |
| Z-1778-2021 | Class II | REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. | Meta C.G.M. SpA | EMI | |
| Z-1777-2021 | Class II | REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. | Meta C.G.M. SpA | EMI | |
| Z-1776-2021 | Class II | REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. | Meta C.G.M. SpA | EMI | |
| Z-1675-2021 | Class II | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122... | Roche Diagnostics GmbH | JJE | |
| Z-1620-2021 | Class I | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1... | Lepu Medical Technology (Beijing) Co., Ltd | QKP | |
| Z-1619-2021 | Class I | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1... | Lepu Medical Technology (Beijing) Co., Ltd | QKO | |
| Z-1796-2021 | Class II | Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. | Philips North America LLC | LNH | |
| Z-1795-2021 | Class II | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November... | Philips North America LLC | LNH | |
| Z-1955-2021 | Class II | Synaptive Trackable Suction Set Standard and Malleable | Synaptive Medical Inc | GCX | |
| Z-1686-2021 | Class II | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices... | CooperSurgical, Inc. | HEW | |
| Z-1901-2021 | Class II | Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product... | Adler MicroMed, Inc. | KDM | |
| Z-1561-2021 | Class II | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package... | Remel Inc | JSO | |
| Z-1549-2021 | Class II | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 | Abbott Medical | GXD | |
| Z-1673-2021 | Class II | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount... | Welch Allyn Inc | DXN | |
| Z-1672-2021 | Class II | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is... | Welch Allyn Inc | DXN | |
| Z-0001-2022 | Class II | RAPTAR Laser Range Finders | Potomac River Group, Corp. | REP | |
| Z-2164-2021 | Class II | Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following... | Innovative Tomography Products GmbH | GAA | |
| Z-2163-2021 | Class II | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following... | Innovative Tomography Products GmbH | GAA | |
| Z-2162-2021 | Class II | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following... | Innovative Tomography Products GmbH | GAA | |
| Z-1830-2021 | Class III | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter... | Terumo Cardiovascular Systems Corporation | DQY | |
| Z-1829-2021 | Class III | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter... | Terumo Cardiovascular Systems Corporation | DQY | |
| Z-1828-2021 | Class III | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter... | Terumo Cardiovascular Systems Corporation | DQY | |
| Z-1838-2021 | Class II | RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1676-2021 | Class II | Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and... | Dentech Corp. | EEF | |
| Z-1621-2021 | Class II | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving... | Boston Scientific Corporation | NIU | |
| Z-1852-2021 | Class II | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF... | Anodyne Surgical | HMX | |
| Z-1674-2021 | Class II | Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in... | Siemens Healthcare Diagnostics Inc. | LIP | |
| Z-1682-2021 | Class II | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic... | PENTAX of America, Inc. | FDT | |
| Z-1685-2021 | Class II | Multitom RAX with software version VF10 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1783-2021 | Class II | Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and... | Elekta Limited | IYE | |
| Z-1859-2021 | Class II | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction... | Medivators Inc | FKQ | |
| Z-1694-2021 | Class II | Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is... | Signature Orthopaedics Pty Limited | MEH | |
| Z-1594-2021 | Class II | Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha... | WillowWood Global LLC | IPM | |
| Z-1773-2021 | Class II | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... | Change Healthcare Canada Company | LLZ | |
| Z-1950-2021 | Class II | Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the... | EHOB, Inc. | IKY | |
| Z-1864-2021 | Class II | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621)... | GE Healthcare | OWB | |
| Z-1927-2021 | Class II | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System... | GE Healthcare | DQK | |
| Z-0498-2022 | Class II | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 | Luminex Corporation | OOI | |
| Z-2579-2021 | Class II | PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 | Aesculap Inc | FZP | |
| Z-2578-2021 | Class II | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | Aesculap Inc | FZP | |
| Z-1944-2021 | Class II | FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 | BioFire Diagnostics, LLC | QBH | |
| Z-1835-2021 | Class II | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. | Hardy Diagnostics | KPA | |
| Z-1791-2021 | Class II | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat... | Terumo Cardiovascular Systems Corporation | DWC | |
| Z-1790-2021 | Class II | The Sarns Temperature Control and Monitor unit (TCM) is a source of... | Terumo Cardiovascular Systems Corporation | DWC |