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-1475-2018 | Class II | ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item... | Zimmer GmbH | LXH | |
| Z-1474-2018 | Class II | M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm... | Zimmer GmbH | LXH | |
| Z-1473-2018 | Class II | Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01 | Zimmer GmbH | LXH | |
| Z-1472-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter... | Zimmer GmbH | FZX | |
| Z-1471-2018 | Class II | Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter... | Zimmer GmbH | LXH | |
| Z-1470-2018 | Class II | ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item... | Zimmer GmbH | LXH | |
| Z-1469-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item... | Zimmer GmbH | HSB | |
| Z-1468-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item... | Zimmer GmbH | HSB | |
| Z-1467-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item... | Zimmer GmbH | HSB | |
| Z-1466-2018 | Class II | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00 | Zimmer GmbH | LXH | |
| Z-1465-2018 | Class II | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length... | Zimmer GmbH | LXH | |
| Z-2501-2018 | Class II | Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559... | Medtronic Navigation, Inc | GEX | |
| Z-2172-2018 | Class II | Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme... | bioMerieux, Inc. | JTO | |
| Z-2171-2018 | Class II | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal... | bioMerieux, Inc. | JTS | |
| Z-2170-2018 | Class II | The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain... | bioMerieux, Inc. | KPA | |
| Z-2169-2018 | Class II | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family... | bioMerieux, Inc. | LGD | |
| Z-2168-2018 | Class II | The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2... | bioMerieux, Inc. | LON | |
| Z-2167-2018 | Class II | The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2... | bioMerieux, Inc. | LON | |
| Z-2166-2018 | Class II | The VITEK 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use... | bioMerieux, Inc. | JSP | |
| Z-2165-2018 | Class II | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the... | bioMerieux, Inc. | JST | |
| Z-2164-2018 | Class II | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2... | bioMerieux, Inc. | LQL | |
| Z-1750-2018 | Class II | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x... | Medtronic Sofamor Danek USA Inc | KWQ | |
| Z-1698-2018 | Class II | Straumann Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W | Straumann USA, LLC | NQA | |
| Z-1697-2018 | Class II | Straumann Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115 | Straumann USA, LLC | NQA | |
| Z-1696-2018 | Class II | Straumann Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W | Straumann USA, LLC | NQA | |
| Z-1695-2018 | Class II | Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 | Straumann USA, LLC | NQA | |
| Z-1694-2018 | Class II | Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 | Straumann USA, LLC | NQA | |
| Z-1693-2018 | Class II | Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | Straumann USA, LLC | NQA | |
| Z-2990-2018 | Class II | GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound... | GE Healthcare | IYN | |
| Z-2989-2018 | Class II | GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound... | GE Healthcare | IYN | |
| Z-2988-2018 | Class II | GE Vivid E95 ultrasound system Product The device is intended for use by a qualified... | GE Healthcare | IYN | |
| Z-2987-2018 | Class II | GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is... | GE Healthcare | IYN | |
| Z-2986-2018 | Class II | GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is... | GE Healthcare | IYN | |
| Z-2985-2018 | Class II | GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a... | GE Healthcare | IYN | |
| Z-2984-2018 | Class II | GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a... | GE Healthcare | IYN | |
| Z-2983-2018 | Class II | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a... | GE Healthcare | IYO | |
| Z-1461-2018 | Class II | Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the... | Cook Incorporated | MQG | |
| Z-1891-2018 | Class II | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the... | Volcano Corporation | IYO | |
| Z-1460-2018 | Class II | Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the... | Cook Incorporated | MQG | |
| Z-1142-2018 | Class I | BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI... | Becton Dickinson & Co | JKA | |
| Z-1141-2018 | Class I | BD Vacutainer EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2... | Becton Dickinson & Co | JKA | |
| Z-1140-2018 | Class I | BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) | Becton Dickinson & Co | JKA | |
| Z-1139-2018 | Class I | BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011)... | Becton Dickinson & Co | JKA | |
| Z-2943-2018 | Class II | Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product... | C.R. Bard Inc | FMH | |
| Z-1900-2018 | Class II | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent... | Madison Polymeric Engineering | MNL | |
| Z-1899-2018 | Class II | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible... | Madison Polymeric Engineering | MNL | |
| Z-1898-2018 | Class II | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit... | Madison Polymeric Engineering | MNL | |
| Z-1897-2018 | Class II | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope... | Madison Polymeric Engineering | MNL | |
| Z-1896-2018 | Class II | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit... | Madison Polymeric Engineering | MNL | |
| Z-1895-2018 | Class II | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit... | Madison Polymeric Engineering | MNL |