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-2135-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with... | Volcano Corporation | IYO | |
| Z-2134-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with... | Volcano Corporation | IYO | |
| Z-2133-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with... | Volcano Corporation | IYO | |
| Z-2132-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with... | Volcano Corporation | IYO | |
| Z-2131-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4... | Volcano Corporation | IYO | |
| Z-2482-2015 | Class II | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality... | Medrad, Inc. | JJX | |
| Z-2271-2015 | Class II | Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in... | Draeger, Inc. | BSZ | |
| Z-2074-2015 | Class II | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval... | Nobel Biocare USA LLC | NDP | |
| Z-2098-2015 | Class II | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The... | CooperSurgical, Inc. | HDX | |
| Z-2346-2015 | Class II | Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 | Atrium Medical Corporation | GBZ | |
| Z-2260-2015 | Class II | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No... | Medtronic, Inc. | FRN | |
| Z-2189-2015 | Class II | T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone... | Argon Medical Devices, Inc | KNW | |
| Z-2188-2015 | Class II | Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow... | Argon Medical Devices, Inc | KNW | |
| Z-2104-2015 | Class II | Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander... | Allergan | LCJ | |
| Z-2103-2015 | Class II | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander... | Allergan | LCJ | |
| Z-1737-2017 | Class II | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto... | Agilent Technologies, Inc. | PJC | |
| Z-2322-2015 | Class III | Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product... | Acon Laboratories, Inc. | DJZ | |
| Z-2072-2015 | Class II | A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. | Zimmer GmbH | HYA | |
| Z-2266-2015 | Class II | Invivo Expression MRI Patient Monitoring System. | Philips North America LLC | MWI | |
| Z-2060-2015 | Class II | ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. | Zimmer GmbH | HSB | |
| Z-0205-2016 | Class II | Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For... | ConMed Corporation | GEI | |
| Z-2382-2015 | Class II | Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port... | B. BRAUN INTERVENTIONAL SYSTEMS Inc. | LJT | |
| Z-1949-2015 | Class II | INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The... | Intuitive Surgical, Inc. | NAY | |
| Z-2316-2015 | Class II | SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps... | Symmetry Surgical GmbH | HXD | |
| Z-2477-2015 | Class II | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08... | Nidek Incorporated | HKO | |
| Z-2361-2015 | Class II | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed... | Abbott Medical | GJS | |
| Z-2081-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for... | LivaNova USA, Inc. | DWC | |
| Z-2080-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal... | LivaNova USA, Inc. | DWC | |
| Z-2079-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal... | LivaNova USA, Inc. | DWC | |
| Z-2078-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal... | LivaNova USA, Inc. | DWC | |
| Z-2077-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal... | LivaNova USA, Inc. | DWC | |
| Z-2076-2015 | Class II | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion... | LivaNova USA, Inc. | DWC | |
| Z-1848-2015 | Class II | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System... | Orthopediatrics Canada ULC | HWC | |
| Z-2190-2015 | Class II | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy... | Mermaid Medical A/S | DWO | |
| Z-2073-2015 | Class II | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have... | Etac Supply Center AB | ILS | |
| Z-2090-2015 | Class III | BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-2052-2015 | Class II | Block Versions Used by Dental Offices often referred to as chairside milling: Lava... | 3M Company | EBF | |
| Z-2715-2017 | Class II | On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased... | Artivion, Inc. | LWQ | |
| Z-2822-2015 | Class II | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. | MicroAire Surgical Instruments, LLC | MUU | |
| Z-2821-2015 | Class II | ASP-1020 LipoTower with Aspiration Pump. Medical use. | MicroAire Surgical Instruments, LLC | MUU | |
| Z-2123-2015 | Class II | GE Healthcare, Precision MPi fluoroscopic imaging systems. | GE Healthcare | JAA | |
| Z-2122-2015 | Class II | GE Healthcare Precision RXi Digital system | GE Healthcare | OWB | |
| Z-2121-2015 | Class II | GE Healthcare Precision RXi 23A/32A Analog System | GE Healthcare | OWB | |
| Z-2120-2015 | Class II | GE Healthcare Precision 500D Classical R & F system. | GE Healthcare | JAA | |
| Z-1966-2015 | Class II | GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic... | GE Healthcare | JAA | |
| Z-2253-2015 | Class II | OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. | Oxysure Systems, Inc. | CAW | |
| Z-1914-2015 | Class II | Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral... | Medtronic Perfusion Systems | DWF | |
| Z-1947-2015 | Class II | Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. | bioMerieux, Inc. | JWY | |
| Z-2146-2015 | Class II | ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial... | Depuy Orthopaedics Inc. | MBH | |
| Z-2145-2015 | Class II | ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation... | Depuy Orthopaedics Inc. | MBH |