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-0360-2022 | Class II | Major Vascular CDS Convenience Kit | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0359-2022 | Class II | Neuro Convenience Kit | MEDLINE INDUSTRIES, LP - Northfield | OJG | |
| Z-0358-2022 | Class II | EVLP Convenience Pack/Kit | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0246-2022 | Class II | The product is a handheld ultraviolet-C germicidal wand and contains two... | Max Lux Corp | RHP | |
| Z-1410-2022 | Class II | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument... | Aesculap Inc | HXX | |
| Z-0265-2022 | Class II | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and... | Smith & Nephew, Inc. | HRS | |
| Z-0333-2022 | Class II | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF... | Northgate Technologies Inc. | FFK | |
| Z-1140-2022 | Class II | ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 | MEDLINE INDUSTRIES, LP - Northfield | CIC | |
| Z-0307-2022 | Class II | The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It... | Atrium Medical Corporation | KDQ | |
| Z-0308-2022 | Class II | Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US)... | Abbott Medical | DSQ | |
| Z-1356-2023 | Class II | ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100... | Philips North America LLC | JAA | |
| Z-1355-2023 | Class II | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030... | Philips North America LLC | JAA | |
| Z-0327-2022 | Class II | HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0326-2022 | Class II | HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0325-2022 | Class II | HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0324-2022 | Class II | HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0323-2022 | Class II | HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0322-2022 | Class II | HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0321-2022 | Class II | HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0320-2022 | Class II | HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the... | Boston Scientific Corporation | FGE | |
| Z-0444-2022 | Class II | Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I... | Advanced Medical Optics, Inc. | OOE | |
| Z-0443-2022 | Class II | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan... | Advanced Medical Optics, Inc. | LZS | |
| Z-0452-2022 | Class II | Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number... | Biomeme, Inc. | QJR | |
| Z-0305-2022 | Class II | Artis Q.zen biplane with software VD12- angiography systems developed for single and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0304-2022 | Class II | Artis Q.zen ceiling with software VD12-angiography systems developed for single and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0303-2022 | Class II | Artis Q.zen floor with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0302-2022 | Class II | Artis Q biplane with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0301-2022 | Class II | Artis Q ceiling with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0300-2022 | Class II | Artis Q floor with software VD12- angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0299-2022 | Class II | Artis zee biplane with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0298-2022 | Class II | Artis zee multi-purpose with software VD12-angiography systems developed for single and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0297-2022 | Class II | Artis zee ceiling with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0296-2022 | Class II | Artis zee floor with software VD12-angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0202-2022 | Class II | Aspiration Syringe Kit, REF: MVSK60 | Terumo Cardiovascular Systems Corporation | FMF | |
| Z-0832-2022 | Class II | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072... | InfuTronix LLC | FRN | |
| Z-0418-2022 | Class II | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | Medtronic Neuromodulation | MHY | |
| Z-0310-2022 | Class II | Total Thyroxine (T4) ELISA; REF EIA-1781 | DRG International, Inc. | KLI | |
| Z-0266-2022 | Class II | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601... | Roche Diagnostics GmbH | KQO | |
| Z-0270-2022 | Class II | Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603 | Western Enterprises, Inc. | CAN | |
| Z-0269-2022 | Class II | Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602 | Western Enterprises, Inc. | CAN | |
| Z-0268-2022 | Class II | Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 | Western Enterprises, Inc. | CAN | |
| Z-0267-2022 | Class II | Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 | Western Enterprises, Inc. | ECX | |
| Z-0331-2022 | Class II | Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0330-2022 | Class II | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0442-2022 | Class II | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part... | Karl Storz Endoscopy-America, Inc. | KCT | |
| Z-0314-2022 | Class II | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 | Howmedica Osteonics Corp | JDG | |
| Z-0313-2022 | Class II | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 | Howmedica Osteonics Corp | JDG | |
| Z-0292-2022 | Class II | Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT... | Medtronic, Inc. | MIH | |
| Z-0291-2022 | Class II | Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE... | Medtronic, Inc. | MIH | |
| Z-0329-2022 | Class II | GE Centricity Universal Viewer Zero Footprint Client | GE Healthcare | LLZ |