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-0292-2018 | Class II | IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue... | Philips North America LLC | MHX | |
| Z-0524-2018 | Class II | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0063-2018 | Class II | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system... | North Star Imaging Inc | RCE | |
| Z-0002-2018 | Class II | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The... | The Binding Site Group Ltd. | DEM | |
| Z-0818-2018 | Class II | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for... | Zimmer GmbH | MBI | |
| Z-0614-2018 | Class II | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0314-2018 | Class II | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by... | Abbott Medical | FRN | |
| Z-0313-2018 | Class II | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths... | Abbott Medical | FRN | |
| Z-3135-2017 | Class II | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an... | Siemens Healthcare Diagnostics Inc. | OYE | |
| Z-1487-2018 | Class II | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | Integra LifeSciences Corporation | ITG | |
| Z-0495-2018 | Class II | Syngo.plaza Picture Archiving and Communication System (PACS) with software version... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0696-2018 | Class II | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one... | OLYMPUS Corporation of the Americas | GCP | |
| Z-0255-2018 | Class II | Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7... | Philips North America LLC | OWB | |
| Z-0263-2018 | Class II | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of... | Invivo Corporation | MWI | |
| Z-0693-2018 | Class II | Coated VICRYL RAPIDETM (Polyglactin 910) Suture | Ethicon, Inc | GAM | |
| Z-0597-2020 | Class II | EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model... | NDD Medical Technologies, Inc. | BTY | |
| Z-0596-2020 | Class II | EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1 | NDD Medical Technologies, Inc. | BTY | |
| Z-0944-2018 | Class II | ReWalk Personal 6.0. Catalog number: 50-20-0004. | Lifeward, Inc. | PHL | |
| Z-0049-2018 | Class II | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue... | Edap Technomed Inc. | PLP | |
| Z-3211-2017 | Class II | IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw | IMRIS Imaging, Inc. | HBL | |
| Z-3213-2017 | Class II | UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The... | Abbott Medical | JOH | |
| Z-3105-2017 | Class II | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on... | Merge Healthcare Incorporated | LLZ | |
| Z-0970-2018 | Class III | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) | Randox Laboratories, Limited | JJY | |
| Z-0969-2018 | Class III | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | Randox Laboratories, Limited | JJY | |
| Z-0082-2018 | Class II | Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is... | Invivo Corporation | MWI | |
| Z-0618-2018 | Class II | Norian Drillable Inject | Synthes (USA) Products LLC | MQV | |
| Z-0617-2018 | Class II | Norian Drillable Inject | Synthes (USA) Products LLC | OIS | |
| Z-0591-2018 | Class II | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System... | Aesculap Inc | HWT | |
| Z-0164-2018 | Class II | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box. | MEDLINE INDUSTRIES, LP - Northfield | IKX | |
| Z-0163-2018 | Class II | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box. | MEDLINE INDUSTRIES, LP - Northfield | IKX | |
| Z-0050-2018 | Class II | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron... | Nucletron BV | MUJ | |
| Z-3083-2017 | Class II | CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red... | Medtec LLC | KXH | |
| Z-3082-2017 | Class II | CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red... | Medtec LLC | KXH | |
| Z-0896-2018 | Class II | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a... | Medtronic Neuromodulation | LKK | |
| Z-0026-2018 | Class II | Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris... | CareFusion 303, Inc | FRN | |
| Z-0823-2018 | Class II | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring... | LifeCell Corp | MUU | |
| Z-0937-2018 | Class II | Liquid Cardiac Control CQ5053 | Randox Laboratories, Limited | JJY | |
| Z-0053-2018 | Class II | Alcon Custom Pak | Alcon Laboratories | LRO | |
| Z-3109-2017 | Class I | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product... | Leonhard Lang GmbH | MKJ | |
| Z-2566-2018 | Class II | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on... | Merge Healthcare Incorporated | LLZ | |
| Z-1808-2018 | Class II | Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during... | Zimmer GmbH | JWH | |
| Z-1807-2018 | Class II | Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during... | Zimmer GmbH | JWH | |
| Z-1806-2018 | Class II | Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during... | Zimmer GmbH | JWH | |
| Z-1805-2018 | Class II | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during... | Zimmer GmbH | JWH | |
| Z-0561-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced)... | Medtronic, Inc. | NEY | |
| Z-0560-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 | Medtronic, Inc. | NEY | |
| Z-0559-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced)... | Medtronic, Inc. | NEY | |
| Z-0558-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1 | Medtronic, Inc. | NEY | |
| Z-0557-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced)... | Medtronic, Inc. | NEY | |
| Z-0556-2018 | Class II | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 | Medtronic, Inc. | NEY |