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-0538-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage... | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-0537-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The... | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-0536-2021 | Class II | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is... | Chromsystems Instruments & Chemicals GmbH | JIX | |
| Z-0902-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-2011-2021 | Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number... | Luminex Corporation | OCC | |
| Z-2010-2021 | Class II | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 | Luminex Corporation | OCC | |
| Z-2009-2021 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 | Luminex Corporation | OCC | |
| Z-2008-2021 | Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 | Luminex Corporation | OCC | |
| Z-2007-2021 | Class II | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 | Luminex Corporation | OCC | |
| Z-2006-2021 | Class II | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 | Luminex Corporation | OCC | |
| Z-0929-2021 | Class II | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to... | Neocis Inc. | PLV | |
| Z-0901-2021 | Class II | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0900-2021 | Class II | Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0899-2021 | Class II | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0898-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to... | Respironics, Inc. | MNT | |
| Z-0897-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0896-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to... | Respironics, Inc. | MNT | |
| Z-0895-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0894-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0893-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0892-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0891-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0890-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0889-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0888-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0887-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0886-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0885-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0514-2021 | Class II | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory... | Invacare GmbH | CAW | |
| Z-0716-2021 | Class II | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel... | Prytime Medical Devices, Inc. | MJN | |
| Z-0523-2021 | Class II | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage... | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-0522-2021 | Class II | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The... | Chromsystems Instruments & Chemicals GmbH | JJY | |
| Z-0521-2021 | Class II | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039... | Chromsystems Instruments & Chemicals GmbH | JIX | |
| Z-0864-2021 | Class II | All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ... | Philips North America LLC | IYN | |
| Z-0558-2021 | Class II | MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating... | Mani, Inc. (Head Office) | NGY | |
| Z-0557-2021 | Class II | MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out... | Mani, Inc. (Head Office) | NGY | |
| Z-0543-2021 | Class II | MAC VU360, Electrocardiograph | GE Healthcare | DPS | |
| Z-0474-2021 | Class II | Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-0473-2021 | Class II | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1381-2021 | Class II | VGlove NITRILE *** Protect Your Life 100 Patient examination gloves | Hubo International Inc | LZA | |
| Z-0655-2021 | Class II | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD... | Hardy Diagnostics | JSM | |
| Z-0513-2021 | Class II | The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that... | Biomeme, Inc. | QJR | |
| Z-0472-2021 | Class II | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software... | Mako Surgical Corp. | OLO | |
| Z-0561-2021 | Class II | Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled... | Medtronic Heart Valves Division | NPT | |
| Z-0560-2021 | Class II | Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled... | Medtronic Heart Valves Division | NPT | |
| Z-0559-2021 | Class II | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV... | Medtronic Heart Valves Division | NPT | |
| Z-0508-2021 | Class II | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a... | Becton Dickinson & Co | FMI | |
| Z-0489-2021 | Class II | Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to... | Intuitive Surgical, Inc. | EOQ | |
| Z-0533-2021 | Class II | PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm | Ethicon, Inc | FTL | |
| Z-0488-2021 | Class II | Titan Pump - Product Usage: indicated for male patients suffering from erectile... | MEDLINE INDUSTRIES, LP - Northfield | FHW |