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-0882-2017 | Class II | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the... | Spinal Elements, Inc | LXH | |
| Z-0734-2017 | Class II | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number... | Accuray Incorporated | IYE | |
| Z-0921-2017 | Class II | SOMATOM Perspective, Computed tomography x-ray system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0920-2017 | Class II | SOMATOM Scope Power, Computed tomography x-ray system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0919-2017 | Class II | SOMATOM Scope, Computed tomography x-ray system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0881-2017 | Class II | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part... | Spinal Elements, Inc | HTY | |
| Z-0966-2017 | Class II | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical... | Spinal Elements, Inc | OVE | |
| Z-0891-2017 | Class II | Optimus Fixed Awl | Spinal Elements, Inc | OVD | |
| Z-0827-2017 | Class II | Zeus-P Lumbar Interbody Device | Spinal Elements, Inc | MAX | |
| Z-0979-2017 | Class II | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH... | Siemens Healthcare Diagnostics Inc. | CEW | |
| Z-1249-2017 | Class II | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated... | Reckitt Benckiser LLC | HIS | |
| Z-1003-2017 | Class II | Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile... | Cormed | ONB | |
| Z-0786-2017 | Class II | AbbVie PEG Kit 20 FR | AbbVie Inc | KNT | |
| Z-0771-2017 | Class II | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only... | Teleflex Medical | KOD | |
| Z-1219-2019 | Class II | CryoPatch SG Pulmonary Hemi-Artery Patch | Artivion, Inc. | DXZ | |
| Z-1052-2017 | Class II | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822... | Eastman Kodak Company | IYN | |
| Z-0916-2017 | Class II | Sfx | GE Healthcare | JAA | |
| Z-0915-2017 | Class II | Rfx | GE Healthcare | IXR | |
| Z-0914-2017 | Class II | Prestilix | GE Healthcare | LLZ | |
| Z-0913-2017 | Class II | Prestige VH | GE Healthcare | JAA | |
| Z-0912-2017 | Class II | Prestige SI | GE Healthcare | JAA | |
| Z-0911-2017 | Class II | Prestige II | GE Healthcare | JAA | |
| Z-0910-2017 | Class II | Precision 500D | GE Healthcare | JAA | |
| Z-0909-2017 | Class II | Legacy | GE Healthcare | JAA | |
| Z-0908-2017 | Class II | Advantx Lcv+ | GE Healthcare | IZI | |
| Z-0907-2017 | Class II | Advantx Lcn+ | GE Healthcare | IZI | |
| Z-0906-2017 | Class II | Advantx Lclp+ | GE Healthcare | IZI | |
| Z-0905-2017 | Class II | Advantx Lca | GE Healthcare | IZI | |
| Z-0948-2017 | Class II | GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use... | Tepha, Incorporated | OOD | |
| Z-1076-2017 | Class II | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers... | Mallinckrodt Manufacturing LLC | MRN | |
| Z-0904-2017 | Class II | Innova 2000 | GE Healthcare | OWB | |
| Z-0763-2017 | Class II | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail... | Sonoma Pharmaceuticals, Inc. | FRO | |
| Z-0789-2017 | Class II | Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety... | Abbott Medical | FOZ | |
| Z-0866-2017 | Class II | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and... | Northgate Technologies Inc. | HIF | |
| Z-0918-2017 | Class II | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17... | Shimadzu Medical Systems | IZO | |
| Z-0917-2017 | Class II | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems | JAA | |
| Z-3191-2018 | Class II | ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging | SWISSRAY Medical, AG | KPR | |
| Z-1511-2017 | Class II | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled... | GE Healthcare | FMT | |
| Z-1510-2017 | Class II | CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled... | GE Healthcare | FMZ | |
| Z-1509-2017 | Class II | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant... | GE Healthcare | FMZ | |
| Z-1508-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant... | GE Healthcare | FMT | |
| Z-1507-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe... | GE Healthcare | FMT | |
| Z-1506-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers... | GE Healthcare | FMT | |
| Z-1505-2017 | Class II | Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant... | GE Healthcare | FMZ | |
| Z-1504-2017 | Class II | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant... | GE Healthcare | FMT | |
| Z-1503-2017 | Class II | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite... | GE Healthcare | LBI | |
| Z-1502-2017 | Class II | Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat... | GE Healthcare | FMZ | |
| Z-1501-2017 | Class II | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient... | GE Healthcare | KZF | |
| Z-1005-2017 | Class II | FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for... | Philips North America LLC | KPR | |
| Z-0787-2017 | Class II | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product... | Vygon Mfg | FPA |