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-1167-2023 | Class II | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1166-2023 | Class II | Luminos dRF with software VD10- A diagnostic imaging system for radiographic and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1165-2023 | Class II | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1164-2023 | Class II | Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1106-2023 | Class II | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on... | Roche Molecular Systems Inc | QLT | |
| Z-1105-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas... | Roche Molecular Systems Inc | QLT | |
| Z-1104-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800... | Roche Molecular Systems Inc | QLT | |
| Z-1132-2023 | Class II | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower... | OLYMPUS Corporation of the Americas | NWB | |
| Z-1200-2023 | Class II | CustomEyes kits | Becton Dickinson & Co | KDD | |
| Z-1199-2023 | Class II | Ultracell Wick with 80cc Collection Bag, 20/box | Becton Dickinson & Co | HOZ | |
| Z-0998-2023 | Class II | Relay Pro, Thoracic Stent-Graft System, Ref 28-N4-Xx-Xxx-Xxx | Bolton Medical Inc. | MIH | |
| Z-0997-2023 | Class II | Relay Pro, Thoracic Stent-Graft System, Ref 28-M4-Xx-Xxx-Xxx | Bolton Medical Inc. | MIH | |
| Z-1280-2023 | Class II | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch... | Withings | DPS | |
| Z-1058-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-1057-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-1056-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-1055-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-1054-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-1053-2023 | Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch... | GE Medical Systems Israel, Functional Imaging | KPS | |
| Z-0951-2023 | Class II | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000... | Depuy Ireland UC | LZN | |
| Z-0886-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75... | Datascope Corp. | DSP | |
| Z-0885-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-1272-2023 | Class II | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW | Vapotherm Inc. | BTT | |
| Z-1050-2023 | Class II | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot... | NeuraSignal, Inc. | IYN | |
| Z-1049-2023 | Class II | Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System | NeuraSignal, Inc. | IYN | |
| Z-1131-2023 | Class II | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | Access Vascular, Inc | FOZ | |
| Z-1130-2023 | Class II | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | Access Vascular, Inc | FOZ | |
| Z-1129-2023 | Class II | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | Access Vascular, Inc | FOZ | |
| Z-1040-2023 | Class II | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1041-2023 | Class II | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | Carbon Medical Technologies, Inc. | NEU | |
| Z-0956-2023 | Class II | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1099-2023 | Class II | HIGH V+ Spinal Cement System REF T040321K | Teknimed SAS | NDN | |
| Z-1044-2023 | Class II | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage... | CooperSurgical, Inc. | MQL | |
| Z-1018-2023 | Class II | Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a... | Zimmer GmbH | HRY | |
| Z-1008-2023 | Class II | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of... | Meridian Bioscience Inc | QJR | |
| Z-1039-2023 | Class II | AxiEM" Non-Invasive Patient Tracker | Medtronic Navigation, Inc | HAW | |
| Z-0948-2023 | Class II | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care... | Gyn-Disposables, Inc. | OWL | |
| Z-0947-2023 | Class II | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. | Gyn-Disposables, Inc. | LRS | |
| Z-0946-2023 | Class II | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags... | Gyn-Disposables, Inc. | LRS | |
| Z-0945-2023 | Class II | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case... | Gyn-Disposables, Inc. | LRS | |
| Z-0944-2023 | Class II | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | Gyn-Disposables, Inc. | FSM | |
| Z-0943-2023 | Class II | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick... | Gyn-Disposables, Inc. | LRS | |
| Z-0942-2023 | Class II | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis... | Gyn-Disposables, Inc. | OWL | |
| Z-0941-2023 | Class II | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology | Gyn-Disposables, Inc. | OFF | |
| Z-0940-2023 | Class II | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology | Gyn-Disposables, Inc. | OFF | |
| Z-0939-2023 | Class II | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care... | Gyn-Disposables, Inc. | FMF | |
| Z-0938-2023 | Class II | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care... | Gyn-Disposables, Inc. | FMF | |
| Z-0937-2023 | Class II | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE... | Gyn-Disposables, Inc. | KPE | |
| Z-0936-2023 | Class II | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE... | Gyn-Disposables, Inc. | KPE | |
| Z-0935-2023 | Class II | Picc Kit, 10/Cs, Access Medical Label | Gyn-Disposables, Inc. | OWL |