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-0838-2022 | Class II | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical... | Ansell Healthcare Products LLC | KGO | |
| Z-1000-2022 | Class II | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either... | Neumodx Molecular, Inc. | QJR | |
| Z-0982-2022 | Class II | ORAcollect RNA: ORE-100 | DNA Genotek Inc. | QJR | |
| Z-0981-2022 | Class II | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100... | DNA Genotek Inc. | OYJ | |
| Z-0897-2022 | Class II | Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation... | Maquet Cardiovascular Us Sales, LLC | DTQ | |
| Z-0860-2022 | Class II | 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic... | GE Healthcare | LNH | |
| Z-0859-2022 | Class II | SIGNA Excite 3T. Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-0858-2022 | Class II | 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-0857-2022 | Class II | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-0822-2022 | Class II | Medical Device products purchased from Family Dollar retail stores located in Alabama... | Dollar Tree Distribution, Inc. | PWC | |
| Z-0900-2022 | Class II | LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445... | Kaneka Medical America LLC | MMY | |
| Z-0934-2022 | Class II | Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of... | IMRIS Imaging, Inc. | HBL | |
| Z-0984-2022 | Class III | Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-1109-2022 | Class II | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Luminex Corporation | PEP | |
| Z-0747-2022 | Class II | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the... | Ion Beam Applications S.A. | LHN | |
| Z-0836-2022 | Class II | Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical... | Meridian Bioscience Inc | OOI | |
| Z-0786-2022 | Class II | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008... | Wright Medical Technology Inc | HRS | |
| Z-0824-2022 | Class III | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Cytocell Limited | PPM | |
| Z-0812-2022 | Class II | BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM... | Zimmer GmbH | JDR | |
| Z-0811-2022 | Class II | BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices... | Zimmer GmbH | JDR | |
| Z-0810-2022 | Class II | BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item #... | Zimmer GmbH | JDR | |
| Z-0809-2022 | Class II | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item... | Zimmer GmbH | JDR | |
| Z-0871-2022 | Class II | Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation... | Draeger, Inc. | CBK | |
| Z-0870-2022 | Class II | Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of... | Draeger, Inc. | CBK | |
| Z-0876-2022 | Class III | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT... | Cook Medical LLC | DTK | |
| Z-0875-2022 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN... | Cook Medical LLC | DTK | |
| Z-0821-2022 | Class II | Compella Therapy Air Supply Unit | Baxter Healthcare Corporation | IOQ | |
| Z-0820-2022 | Class II | Compella Bariatric Bed System | Baxter Healthcare Corporation | IOQ | |
| Z-1088-2024 | Class II | CombiDiagnost R90 1.1 (709031) | Philips North America LLC | JAA | |
| Z-1087-2024 | Class II | CombiDiagnost R90 1.0 (709030) | Philips North America LLC | JAA | |
| Z-0850-2022 | Class II | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0... | RaySearch Americas Inc. | MUJ | |
| Z-0710-2022 | Class II | Alinity m Integrated Reaction Units (IRU) | Abbott Molecular, Inc. | OOI | |
| Z-0960-2022 | Class II | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10... | Huntleigh Healthcare Ltd. | ITX | |
| Z-0914-2022 | Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument | Medartis AG | HWC | |
| Z-0913-2022 | Class II | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC... | Medartis AG | HWC | |
| Z-0912-2022 | Class II | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic... | Medartis AG | HWC | |
| Z-0911-2022 | Class II | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC... | Medartis AG | HWC | |
| Z-0910-2022 | Class II | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K... | Medartis AG | HWC | |
| Z-0887-2022 | Class II | Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. | Maquet Cardiovascular LLC | DWS | |
| Z-0931-2022 | Class II | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 | Siemens Healthcare Diagnostics Inc. | NDW | |
| Z-0930-2022 | Class II | Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 | Siemens Healthcare Diagnostics Inc. | LCP | |
| Z-0929-2022 | Class II | Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 | Siemens Healthcare Diagnostics Inc. | PDJ | |
| Z-0928-2022 | Class II | Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 | Siemens Healthcare Diagnostics Inc. | CJY | |
| Z-0742-2022 | Class II | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | bioMerieux, Inc. | LKQ | |
| Z-0679-2022 | Class II | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of... | Wright Medical Technology Inc | HRS | |
| Z-0807-2022 | Class II | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL | Bio-Rad Laboratories Inc. | LIP | |
| Z-0806-2022 | Class II | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack | Bio-Rad Laboratories Inc. | LIP | |
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the... | Philips North America LLC | FFL | |
| Z-0819-2022 | Class II | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to... | B Braun Medical Inc | MEA | |
| Z-0890-2022 | Class II | Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only... | BRIUS Technologies Inc. | DYJ |