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-1852-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM... | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-2079-2019 | Class III | ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation... | Abbott Medical | JJX | |
| Z-2078-2019 | Class III | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the... | Abbott Medical | JIT | |
| Z-1766-2019 | Class I | Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code... | Teleflex Medical | BTR | |
| Z-1765-2019 | Class I | Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway... | Teleflex Medical | BTR | |
| Z-1764-2019 | Class I | Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code... | Teleflex Medical | BTR | |
| Z-1763-2019 | Class I | Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product... | Teleflex Medical | BTR | |
| Z-1762-2019 | Class I | Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c)... | Teleflex Medical | BTR | |
| Z-1761-2019 | Class I | Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product... | Teleflex Medical | BTR | |
| Z-1760-2019 | Class I | Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product... | Teleflex Medical | BTR | |
| Z-1759-2019 | Class I | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway... | Teleflex Medical | BTR | |
| Z-1758-2019 | Class I | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number... | Cook Incorporated | PNO | |
| Z-1757-2019 | Class I | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number... | Cook Incorporated | PNO | |
| Z-1756-2019 | Class I | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number... | Cook Incorporated | PNO | |
| Z-1805-2020 | Class II | Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version... | Medtimo, Inc. | LTI | |
| Z-0259-2020 | Class II | Various products which were contract sterilized. | Anewmed Corporation | DQX | |
| Z-2360-2019 | Class II | DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a... | Leventon S. A. U. | MEB | |
| Z-1957-2019 | Class II | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a... | Richard Wolf Medical Instruments Corp. | HIH | |
| Z-1688-2020 | Class II | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH... | Abbott Medical | JIT | |
| Z-1781-2019 | Class II | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model... | GE Healthcare | LLZ | |
| Z-2252-2021 | Class II | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC... | Dutch Ophthalmic USA, Inc. | HQC | |
| Z-2159-2019 | Class II | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human... | DRG Instruments GmbH | CDZ | |
| Z-1884-2019 | Class II | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of... | Medtronic, Inc. | DYE | |
| Z-1883-2019 | Class II | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of... | Medtronic, Inc. | DYE | |
| Z-1882-2019 | Class II | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of... | Medtronic, Inc. | DYE | |
| Z-1881-2019 | Class II | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of... | Medtronic, Inc. | DYE | |
| Z-1880-2019 | Class II | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of... | Medtronic, Inc. | DYE | |
| Z-2201-2019 | Class II | The Alinity ci-series System Control Modules which are configured with Alinity c... | Abbott Medical | JJE | |
| Z-1839-2019 | Class II | LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend... | GE Healthcare | IYN | |
| Z-2106-2020 | Class II | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the... | Medtronic, Inc. | MDS | |
| Z-2223-2019 | Class II | The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test... | Opternative Inc | OUG | |
| Z-1778-2019 | Class II | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1777-2019 | Class II | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1741-2020 | Class II | Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1886-2019 | Class II | Centricity Universal Viewer with PACS-IW foundation 6.0, Model number... | GE Healthcare | LLZ | |
| Z-1885-2019 | Class II | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product... | GE Healthcare | LLZ | |
| Z-0053-2020 | Class II | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1836-2019 | Class II | Signia Tri-Staple 2.0 Curved Tip 60Mm Medium/ Thic , Sig60ctamt | Medtronic, Inc. | GDW | |
| Z-1835-2019 | Class II | Signia Tri-Staple 2.0 Curved Tip 45Mm Medium/ Thic , Sig45ctamt | Medtronic, Inc. | GDW | |
| Z-1834-2019 | Class II | Signia Tri-Staple 2.0 Black 60Mm Extra Thick Reloa, Sig60axt | Medtronic, Inc. | GDW | |
| Z-1833-2019 | Class II | Signia Tri-Staple 2.0 Black 45Mm Extra Thick Reloa, Sig45axt | Medtronic, Inc. | GDW | |
| Z-1832-2019 | Class II | Signia Tri-Staple 2.0 30Mm Medium/ Thick Reload , Sig30amt | Medtronic, Inc. | GDW | |
| Z-1831-2019 | Class II | Egia45 CT Ar Md Thk Rel, Egia45ctamt | Medtronic, Inc. | GDW | |
| Z-1830-2019 | Class II | Egia 60 Curved Tip Art Med Thick Sulu, Egia60ctamt | Medtronic, Inc. | GDW | |
| Z-1829-2019 | Class II | Egia 60 Articulating Med Thick Sulu , Egia60amt | Medtronic, Inc. | GDW | |
| Z-1828-2019 | Class II | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | Medtronic, Inc. | GDW | |
| Z-1827-2019 | Class II | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | Medtronic, Inc. | GDW | |
| Z-1826-2019 | Class II | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | Medtronic, Inc. | GDW | |
| Z-1825-2019 | Class II | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | Medtronic, Inc. | GDW | |
| Z-2280-2019 | Class II | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Cerenovus, Inc. | HCG |