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-0915-2022 | Class II | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy | Boston Scientific Corporation | MCX | |
| Z-0997-2022 | Class II | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0996-2022 | Class II | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0995-2022 | Class II | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0994-2022 | Class II | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180... | Siemens Medical Solutions USA, Inc. | MUJ | |
| Z-0962-2022 | Class II | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 &... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1010-2022 | Class II | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0730-2022 | Class II | YSIO X.Pree | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0944-2022 | Class I | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test | SML Distribution, LLC | QKP | |
| Z-1012-2022 | Class II | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient... | Draeger Medical Systems, Inc. | MHX | |
| Z-0983-2022 | Class II | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA... | GE Healthcare | LNH | |
| Z-0898-2022 | Class II | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection... | MEDLINE INDUSTRIES, LP - Northfield | NGT | |
| Z-0884-2022 | Class II | Alinity m HBV AMP Kit (US and CE) | Abbott Molecular, Inc. | MKT | |
| Z-0883-2022 | Class II | Alinity m HBV Application Specification File (US and CE) | Abbott Molecular, Inc. | MKT | |
| Z-0892-2022 | Class II | First SIGN SARS-CoV-2 Antigen Test | WHPM Inc. | QKP | |
| Z-1077-2022 | Class I | iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405... | Atrium Medical Corporation | JCT | |
| Z-1025-2022 | Class II | ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1024-2022 | Class II | ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1023-2022 | Class II | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1022-2022 | Class II | Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1021-2022 | Class II | Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1020-2022 | Class II | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-1082-2022 | Class II | EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile... | Boston Scientific Corporation | FDT | |
| Z-1081-2022 | Class II | EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile... | Boston Scientific Corporation | FDT | |
| Z-1080-2022 | Class II | EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile... | Boston Scientific Corporation | FDT | |
| Z-1079-2022 | Class II | EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile... | Boston Scientific Corporation | FDT | |
| Z-1076-2022 | Class I | Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320... | Atrium Medical Corporation | JCT | |
| Z-0844-2022 | Class II | Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing... | Microbiologics, Inc. | OHQ | |
| Z-0880-2022 | Class II | DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine... | DeRoyal Industries, Inc. | LRO | |
| Z-0879-2022 | Class II | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and... | DeRoyal Industries, Inc. | LRO | |
| Z-0878-2022 | Class II | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine... | DeRoyal Industries, Inc. | OXQ | |
| Z-1210-2022 | Class II | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF... | Intuitive Surgical, Inc. | GEI | |
| Z-1209-2022 | Class II | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da... | Intuitive Surgical, Inc. | NAY | |
| Z-1031-2022 | Class II | First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and... | Aso LLC | LRR | |
| Z-0927-2022 | Class I | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve... | Medtronic, Inc. | NPV | |
| Z-0904-2022 | Class II | AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C... | Merit Medical Systems, Inc. | DTL | |
| Z-0903-2022 | Class II | Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H... | Merit Medical Systems, Inc. | DTL | |
| Z-0835-2022 | Class II | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 | Edwards Lifesciences LLC | MUD | |
| Z-0834-2022 | Class II | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA... | Edwards Lifesciences LLC | MUD | |
| Z-1762-2022 | Class II | NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of... | Malvern Panalytical Ltd | REN | |
| Z-1761-2022 | Class II | NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of... | Malvern Panalytical Ltd | REN | |
| Z-0906-2022 | Class II | Integra Universal Flexible Arm part number REF 1362275 | Integra LifeSciences Corporation | FXG | |
| Z-0998-2022 | Class II | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a)... | Medtronic Neuromodulation | EZW | |
| Z-0950-2022 | Class II | Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access... | Resource Optimization & Innovation, LLC | LRS | |
| Z-0909-2022 | Class I | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011))... | Respironics, Inc. | MNT | |
| Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) | Respironics, Inc. | MNT | |
| Z-0907-2022 | Class I | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615... | Respironics, Inc. | MNT | |
| Z-1563-2022 | Class II | DigitalDiagnost C50 1.1 | Philips North America LLC | KPR | |
| Z-1339-2022 | Class II | syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0952-2022 | Class II | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) | Qiagen | OWD |