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-1721-2023 | Class I | ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1720-2023 | Class I | ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1719-2023 | Class I | ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1718-2023 | Class I | ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1717-2023 | Class I | ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1716-2023 | Class I | ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1715-2023 | Class I | ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1714-2023 | Class I | ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1713-2023 | Class I | ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1712-2023 | Class I | ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1711-2023 | Class I | ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1710-2023 | Class I | ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1709-2023 | Class I | ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1708-2023 | Class I | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1707-2023 | Class I | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1706-2023 | Class I | ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1705-2023 | Class I | ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1704-2023 | Class I | ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1633-2023 | Class I | Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring... | BearCare, Inc. | FQZ | |
| Z-2005-2023 | Class II | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part... | Permobil, AB | ITI | |
| Z-2004-2023 | Class II | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part... | Permobil, AB | ITI | |
| Z-2215-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and... | Qiagen | QJR | |
| Z-2235-2023 | Class II | vRad PACS with Mammography | Virtual Radiologic Corporation | LLZ | |
| Z-2129-2023 | Class II | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS... | Ortho-Clinical Diagnostics, Inc. | JIT | |
| Z-2440-2023 | Class II | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797... | BioFire Diagnostics, LLC | QBH | |
| Z-2439-2023 | Class II | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only | BioFire Diagnostics, LLC | QOF | |
| Z-1969-2023 | Class II | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17... | Galt Medical Corp | DYB | |
| Z-1968-2023 | Class II | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Galt Medical Corp | DYB | |
| Z-1825-2023 | Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Remote Diagnostic Technologies Ltd. | LDD | |
| Z-1665-2023 | Class II | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta... | Elekta Limited | IYE | |
| Z-1967-2023 | Class II | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator | Jaeger Medical GmbH | CBK | |
| Z-1966-2023 | Class II | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator | Jaeger Medical GmbH | CBK | |
| Z-2065-2023 | Class II | Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation... | T.A.G. Medical Products Corporation Ltd | LXH | |
| Z-2064-2023 | Class II | Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation... | T.A.G. Medical Products Corporation Ltd | LXH | |
| Z-2063-2023 | Class II | BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation... | T.A.G. Medical Products Corporation Ltd | LXH | |
| Z-2062-2023 | Class II | BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in... | T.A.G. Medical Products Corporation Ltd | LXH | |
| Z-2061-2023 | Class II | BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in... | T.A.G. Medical Products Corporation Ltd | MBI | |
| Z-2060-2023 | Class II | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in... | T.A.G. Medical Products Corporation Ltd | MBI | |
| Z-2022-2023 | Class III | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control... | Randox Laboratories, Limited | JJY | |
| Z-2021-2023 | Class III | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material... | Randox Laboratories, Limited | JJY | |
| Z-1990-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal... | OLYMPUS Corporation of the Americas | PKL | |
| Z-1989-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal... | OLYMPUS Corporation of the Americas | PKL | |
| Z-1988-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal... | OLYMPUS Corporation of the Americas | PKL | |
| Z-1987-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal... | OLYMPUS Corporation of the Americas | PKL | |
| Z-1907-2023 | Class III | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part... | Datascope Corp. | DSP | |
| Z-1921-2023 | Class II | Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 | Howmedica Osteonics Corp | LXH | |
| Z-1982-2023 | Class II | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015... | MEDLINE INDUSTRIES, LP - Northfield | FRO | |
| Z-1689-2023 | Class II | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants... | Bolton Medical Inc. | MIH | |
| Z-1667-2023 | Class I | NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device | Noxbox Limited | MRN | |
| Z-2037-2023 | Class II | Legacy Smartbase, Ne 3.0D 1Mml, Ref: 8730-81Ne; Legacy Smartbase, Ne 3.0D 2Mml, Ref... | Implant Direct Sybron Manufacturing LLC | NHA |