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-1638-2024 | Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012... | Boston Scientific Corporation | DQO | |
| Z-2270-2024 | Class II | 24K Premium Lense, Distributed by Updream Inc. | Ontact Inc | MVN | |
| Z-1775-2024 | Class II | Baxter Spectrum IQ Infusion Pump, Product Code 3570009 | Baxter Healthcare Corporation | FRN | |
| Z-1729-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for... | Zimmer GmbH | HWC | |
| Z-1728-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for... | Zimmer GmbH | HWC | |
| Z-1727-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1726-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1725-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1724-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1723-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1722-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4... | Zimmer GmbH | HWC | |
| Z-1721-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16... | Zimmer GmbH | HWC | |
| Z-1720-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for... | Zimmer GmbH | HWC | |
| Z-1719-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12... | Zimmer GmbH | HWC | |
| Z-1718-2024 | Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10... | Zimmer GmbH | HWC | |
| Z-1717-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8... | Zimmer GmbH | HWC | |
| Z-1716-2024 | Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6... | Zimmer GmbH | HWC | |
| Z-1715-2024 | Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary... | Zimmer GmbH | HWC | |
| Z-1714-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16... | Zimmer GmbH | HWC | |
| Z-1713-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12... | Zimmer GmbH | HWC | |
| Z-1712-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10... | Zimmer GmbH | HWC | |
| Z-1711-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8... | Zimmer GmbH | HWC | |
| Z-1710-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6... | Zimmer GmbH | HWC | |
| Z-1709-2024 | Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4... | Zimmer GmbH | HWC | |
| Z-1512-2024 | Class I | Drger Perseus A500 Anesthesia Workstation | Draeger, Inc. | BSZ | |
| Z-1633-2024 | Class II | 3M Durapore Surgical Tape, Catalog Number 1538-118 | 3M Company | KGX | |
| Z-1602-2024 | Class II | Alinity m System, Part Number: 08N53-002 | Abbott Molecular, Inc. | OOI | |
| Z-1792-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx... | Trimed Inc | HWC | |
| Z-1791-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx... | Trimed Inc | HWC | |
| Z-1505-2024 | Class I | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for... | Respironics, Inc. | CBK | |
| Z-1805-2024 | Class II | Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model... | Medtronic Perfusion Systems | DWF | |
| Z-1804-2024 | Class II | Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number... | Medtronic Perfusion Systems | DTS | |
| Z-1803-2024 | Class II | Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model... | Medtronic Perfusion Systems | DWF | |
| Z-1802-2024 | Class II | Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number... | Medtronic Perfusion Systems | DXS | |
| Z-1801-2024 | Class II | Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line... | Medtronic Perfusion Systems | DWF | |
| Z-1800-2024 | Class II | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic... | Medtronic Perfusion Systems | DWF | |
| Z-1799-2024 | Class II | Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number... | Medtronic Perfusion Systems | DWF | |
| Z-1798-2024 | Class II | Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number... | Medtronic Perfusion Systems | GDJ | |
| Z-1797-2024 | Class II | Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number... | Medtronic Perfusion Systems | DWF | |
| Z-1796-2024 | Class II | Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 | Medtronic Perfusion Systems | DWF | |
| Z-1795-2024 | Class II | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 | Medtronic Perfusion Systems | DWF | |
| Z-1794-2024 | Class II | Medtronic Clearview Blower/Mister, Model Number 22120 | Medtronic Perfusion Systems | FQH | |
| Z-1793-2024 | Class II | Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20... | Medtronic Perfusion Systems | DWF | |
| Z-1504-2024 | Class I | Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult... | Respironics, Inc. | CBK | |
| Z-1503-2024 | Class I | Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and... | Respironics, Inc. | CBK | |
| Z-1502-2024 | Class I | Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and... | Respironics, Inc. | CBK | |
| Z-1501-2024 | Class I | LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult... | Respironics, Inc. | CBK | |
| Z-1500-2024 | Class I | Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult... | Respironics, Inc. | CBK | |
| Z-1499-2024 | Class I | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult... | Respironics, Inc. | CBK | |
| Z-1774-2024 | Class II | BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining... | Boston Scientific Corporation | MSD |
