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-1892-2016 | Class I | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator... | Jaeger Medical GmbH | CBK | |
| Z-1891-2016 | Class I | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator... | Jaeger Medical GmbH | CBK | |
| Z-1890-2016 | Class I | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator... | Jaeger Medical GmbH | CBK | |
| Z-1889-2016 | Class I | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to... | Jaeger Medical GmbH | CBK | |
| Z-1888-2016 | Class I | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended... | Jaeger Medical GmbH | CBK | |
| Z-2143-2016 | Class III | enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2133-2016 | Class II | 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC. | Lifeline First Aid LLC | CBP | |
| Z-2132-2016 | Class II | Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter... | Lifeline First Aid LLC | CBP | |
| Z-1995-2016 | Class II | Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to... | Fsc Laboratories, Inc. | NVP | |
| Z-2769-2016 | Class II | Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive... | Innovision, Inc. | BZC | |
| Z-2085-2016 | Class II | Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R... | Medtronic Powered Surgical Solutions | HBE | |
| Z-1935-2016 | Class II | MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr... | Datascope Corp. | DSP | |
| Z-2064-2016 | Class II | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central... | CareFusion 303, Inc | FRN | |
| Z-1840-2016 | Class II | COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular... | Baxter Healthcare Corporation | NBE | |
| Z-1839-2016 | Class II | COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular... | Baxter Healthcare Corporation | NBE | |
| Z-1838-2016 | Class II | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular... | Baxter Healthcare Corporation | NBE | |
| Z-1705-2016 | Class II | iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a... | Elekta Limited | IYE | |
| Z-2404-2016 | Class II | Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid... | MEDLINE INDUSTRIES, LP - Northfield | KYW | |
| Z-2087-2016 | Class II | Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or... | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-1944-2016 | Class II | Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or... | Synthes (USA) Products LLC | MQV | |
| Z-1943-2016 | Class II | Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or... | Synthes (USA) Products LLC | MQV | |
| Z-1942-2016 | Class II | Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or... | Synthes (USA) Products LLC | MQV | |
| Z-1917-2016 | Class II | Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and... | Zimmer GmbH | MBH | |
| Z-2043-2016 | Class II | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version... | FUJIFILM Healthcare Americas Corporation | LLZ | |
| Z-1991-2016 | Class II | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of... | CarboFix Orthopedics Inc. | HSB | |
| Z-2705-2016 | Class II | Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid... | Medical Vision AB | HRX | |
| Z-2038-2016 | Class II | SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and... | Cell Marque Corp. | NJT | |
| Z-1965-2016 | Class II | TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The... | Integra LifeSciences Corporation | HRS | |
| Z-2088-2016 | Class II | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2145-2016 | Class III | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique... | Ortho-Clinical Diagnostics, Inc. | LOJ | |
| Z-2002-2016 | Class II | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with... | Datascope Corp. | DWE | |
| Z-1928-2016 | Class II | Optima 1.5T MR430s MR Scanner, a diagnostic imaging device | GE Healthcare | LNH | |
| Z-1927-2016 | Class II | MSK 1.5T Extreme MR Scanner, a diagnostic imaging device | GE Healthcare | LNH | |
| Z-1915-2016 | Class II | GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray... | GE Healthcare | JAK | |
| Z-1837-2016 | Class II | SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06... | Intuitive Surgical, Inc. | NAY | |
| Z-1836-2016 | Class II | SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05... | Intuitive Surgical, Inc. | GCY | |
| Z-2040-2016 | Class II | Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and... | IMMY, Inc. | GMJ | |
| Z-1672-2016 | Class II | Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the... | Medtronic Navigation, Inc | GEX | |
| Z-2216-2016 | Class II | cobas Liat Analyzer | Roche Molecular Systems Inc | OCC | |
| Z-2251-2016 | Class II | Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and... | Best Theratronics Ltd. | MOT | |
| Z-2130-2016 | Class II | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous... | Wassenburg Medical B.V. | NVE | |
| Z-2294-2016 | Class II | Endotine Transbleph 3.5 (CFD-080-0167) | MicroAire Surgical Instruments, LLC | HWC | |
| Z-1948-2016 | Class III | Ariol is an automated scanning microscope and image analysis system. It is intended for... | Leica Biosystems Richmond, Inc. | NQN | |
| Z-2688-2016 | Class II | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil... | Invivo Corporation | MOS | |
| Z-1217-2017 | Class III | The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine... | Siemens Healthcare Diagnostics Inc. | JIT | |
| Z-1216-2017 | Class III | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-1990-2016 | Class II | Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are... | Stryker Medical | FPO | |
| Z-1698-2016 | Class II | Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products. | Ellipse A/S | GEX | |
| Z-1697-2016 | Class II | Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products. | Ellipse A/S | GEX | |
| Z-1924-2016 | Class II | Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a... | Medical Components, Inc. | DYB |