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-0770-2020 | Class II | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000... | Carl Zeiss Meditec Inc | OBO | |
| Z-0296-2020 | Class II | Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the... | Argon Medical Devices, Inc | DRS | |
| Z-0295-2020 | Class II | Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm... | Argon Medical Devices, Inc | DRS | |
| Z-0294-2020 | Class II | Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only... | Argon Medical Devices, Inc | DRS | |
| Z-0293-2020 | Class II | (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF... | Argon Medical Devices, Inc | DRS | |
| Z-0292-2020 | Class II | Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile... | Argon Medical Devices, Inc | DRS | |
| Z-0291-2020 | Class II | Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF... | Argon Medical Devices, Inc | DRS | |
| Z-0290-2020 | Class II | (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF... | Argon Medical Devices, Inc | DRS | |
| Z-0289-2020 | Class II | Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The... | Argon Medical Devices, Inc | DRS | |
| Z-0288-2020 | Class II | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male... | Argon Medical Devices, Inc | DRS | |
| Z-1958-2019 | Class II | Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... | Canon Medical Systems USA, Inc. | MQB | |
| Z-0731-2019 | Class II | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number... | ConforMIS, Inc. | LPH | |
| Z-2138-2019 | Class II | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100... | Med-el Elektromedizinische Geraete, GmbH | PGQ | |
| Z-2137-2019 | Class II | MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types... | Med-el Elektromedizinische Geraete, GmbH | PGQ | |
| Z-2136-2019 | Class II | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant... | Med-el Elektromedizinische Geraete, GmbH | PGQ | |
| Z-0525-2019 | Class II | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached... | Aso LLC | NAB | |
| Z-0617-2019 | Class II | Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0616-2019 | Class II | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0596-2019 | Class II | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP)... | Boston Scientific Corporation | LJS | |
| Z-0595-2019 | Class II | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no... | Boston Scientific Corporation | LJS | |
| Z-0629-2019 | Class II | Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202... | Jarvik Heart Inc | DSQ | |
| Z-2554-2019 | Class II | Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS)... | Abbott Medical | LKK | |
| Z-0560-2019 | Class II | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 | Atrium Medical Corporation | GBZ | |
| Z-0642-2019 | Class II | Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress... | Zimmer GmbH | KWA | |
| Z-0799-2019 | Class II | ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR... | Abbott Ireland Diagnostics Division | CDP | |
| Z-0798-2019 | Class II | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR... | Abbott Ireland Diagnostics Division | CDP | |
| Z-0593-2019 | Class II | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170... | Abbott Medical | MHY | |
| Z-0499-2019 | Class II | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro... | Siemens Healthcare Diagnostics Inc. | CFJ | |
| Z-1349-2019 | Class II | M200 Fall Monitoring System | Securitas Healthcare LLC | KMI | |
| Z-0375-2019 | Class II | Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images... | GE Healthcare | LLZ | |
| Z-0374-2019 | Class II | Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays... | GE Healthcare | LLZ | |
| Z-0030-2020 | Class II | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path... | Baxter Healthcare Corporation | FKX | |
| Z-0592-2019 | Class II | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product... | Philips North America LLC | DSI | |
| Z-0591-2019 | Class II | Comprehensive Mini Stem, Item No. 113631: | Zimmer GmbH | MBF | |
| Z-0590-2019 | Class II | Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 | Zimmer GmbH | KRO | |
| Z-0813-2019 | Class II | Naera Hospital Bassinet, Model No. 4402 | Stryker Medical | NZG | |
| Z-0175-2019 | Class II | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The... | Philips North America LLC | MKJ | |
| Z-0643-2019 | Class II | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements... | Theragenics Corp. | IWJ | |
| Z-0518-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0517-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0516-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0470-2019 | Class I | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product... | Synaptive Medical Inc | HAW | |
| Z-0478-2019 | Class II | Insulia Diabetes Management Companion | Voluntis | NDC | |
| Z-0476-2019 | Class II | VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to... | Ortho-Clinical Diagnostics, Inc. | MRR | |
| Z-0443-2019 | Class II | bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134 | bioMerieux, Inc. | PPM | |
| Z-0439-2019 | Class II | The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option | Stryker Medical | FNL | |
| Z-0438-2019 | Class II | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option | Stryker Medical | FNL | |
| Z-0663-2019 | Class II | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per... | Abbott Medical | KRB | |
| Z-0041-2020 | Class II | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and... | GE Healthcare | FMZ | |
| Z-0461-2019 | Class II | Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The... | Medtronic, Inc. | FTL |