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-1660-2023 | Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1659-2023 | Class II | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1658-2023 | Class II | QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1643-2023 | Class II | QUADROX-iR, used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTQ | |
| Z-1642-2023 | Class II | Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTN | |
| Z-1641-2023 | Class II | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTR | |
| Z-1640-2023 | Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1639-2023 | Class II | BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1638-2023 | Class II | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1637-2023 | Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-2109-2023 | Class II | Allen Advance Chest Support with Pad | Baxter Healthcare Corporation | GDC | |
| Z-1657-2023 | Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1656-2023 | Class II | QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1655-2023 | Class II | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1636-2023 | Class II | BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1635-2023 | Class II | BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1634-2023 | Class II | HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-2043-2023 | Class II | Access Hybritech p2PSA reagent, REF B03704 and REF A49752. | Siemens Healthcare Diagnostics Inc. | OYA | |
| Z-2148-2023 | Class II | Aeris Balloon Dilation Catheter | Bryan Medical Inc | KTI | |
| Z-2091-2023 | Class II | Aptio Automation Storage and Retrieval Module (SRM) | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1992-2023 | Class II | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1... | Draeger Medical Systems, Inc. | FMT | |
| Z-1993-2023 | Class II | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor... | HeartWare, Inc. | DSQ | |
| Z-2339-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | PXP | |
| Z-2338-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2337-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-2336-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OKV | |
| Z-2335-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OJF | |
| Z-2334-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OHM | |
| Z-2333-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OHD | |
| Z-2332-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | MLS | |
| Z-2331-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OJG | |
| Z-2330-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | NSB | |
| Z-2329-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LYU | |
| Z-2328-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | KKX | |
| Z-2327-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FMH | |
| Z-2326-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | PKD | |
| Z-2325-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OXQ | |
| Z-2324-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | MCY | |
| Z-2323-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LRS | |
| Z-2322-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LRP | |
| Z-2279-2023 | Class II | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE... | GE Healthcare | OXO | |
| Z-2321-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2320-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2319-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2318-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | KDD | |
| Z-2317-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FTN | |
| Z-2316-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | PPB | |
| Z-2315-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OHR | |
| Z-2314-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | NWU | |
| Z-2313-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FKG |