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-2281-2015 | Class II | ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2280-2015 | Class II | ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-1667-2015 | Class II | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-1616-2015 | Class II | COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic... | Siemens Healthcare Diagnostics Inc. | GIF | |
| Z-0811-2016 | Class II | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The... | Verathon Inc. | CCW | |
| Z-1579-2015 | Class II | EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ... | Philips North America LLC | IYN | |
| Z-1578-2015 | Class II | EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ... | Philips North America LLC | IYN | |
| Z-1546-2015 | Class II | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval... | Orthopediatrics Canada ULC | HSB | |
| Z-1681-2015 | Class II | Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40... | Medtronic Neuromodulation | LKK | |
| Z-1547-2015 | Class II | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for... | Alphatec Spine, Inc. | KWQ | |
| Z-2715-2016 | Class II | Merge RadSuite software. Radiological image processing system. | Merge Healthcare Incorporated | LLZ | |
| Z-1986-2015 | Class II | Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise... | Bte Technologies | ISD | |
| Z-1629-2015 | Class II | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of... | Siemens Healthcare Diagnostics Inc. | CEE | |
| Z-1600-2015 | Class II | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in... | Synthes GmbH | HSB | |
| Z-1586-2015 | Class II | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD... | Bard Peripheral Vascular Inc | KNW | |
| Z-1538-2015 | Class II | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number... | MEDLINE INDUSTRIES, LP - Northfield | FAE | |
| Z-1597-2015 | Class III | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal... | Spinal Elements, Inc | NKB | |
| Z-1628-2015 | Class II | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product... | Baxter Corporation Englewood | NEP | |
| Z-1823-2015 | Class II | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452... | Xtant Medical Holdings, Inc. | MNH | |
| Z-1481-2015 | Class II | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For... | Biomerics | HGS | |
| Z-1729-2015 | Class II | Assay Data Disk (ADD), All DRV versions that support product within expiry... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1728-2015 | Class II | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1743-2015 | Class II | VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1742-2015 | Class II | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1537-2015 | Class II | Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay... | GA Industries | MYN | |
| Z-2063-2016 | Class II | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of... | Horiba Instruments Incorporated | LPS | |
| Z-1609-2015 | Class I | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator... | Jaeger Medical GmbH | CBK | |
| Z-2403-2015 | Class II | Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner... | Champion Mfg, Inc. | INN | |
| Z-2402-2015 | Class II | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient... | Champion Mfg, Inc. | INN | |
| Z-2401-2015 | Class II | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology... | Champion Mfg, Inc. | INN | |
| Z-2400-2015 | Class II | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology... | Champion Mfg, Inc. | INN | |
| Z-2399-2015 | Class II | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital... | Champion Mfg, Inc. | INN | |
| Z-2398-2015 | Class II | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery... | Champion Mfg, Inc. | INN | |
| Z-2397-2015 | Class II | Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital... | Champion Mfg, Inc. | INN | |
| Z-2396-2015 | Class II | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital... | Champion Mfg, Inc. | INN | |
| Z-2395-2015 | Class II | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital... | Champion Mfg, Inc. | INN | |
| Z-2394-2015 | Class II | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery... | Champion Mfg, Inc. | INN | |
| Z-2393-2015 | Class II | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery... | Champion Mfg, Inc. | INN | |
| Z-2392-2015 | Class II | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home... | Champion Mfg, Inc. | INN | |
| Z-2391-2015 | Class II | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing... | Champion Mfg, Inc. | INN | |
| Z-1636-2015 | Class II | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection. | Strata Skin Sciences, Inc. | OYD | |
| Z-1706-2015 | Class I | FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-1575-2015 | Class II | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be... | Zimmer GmbH | JWH | |
| Z-1615-2015 | Class II | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2085-2015 | Class II | Patient Handling System (Motion Control Software), Product Usage: Indicated for... | Viewray Systems, Inc. | IYE | |
| Z-1548-2015 | Class II | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis... | Agilent Technologies, Inc. | KPA | |
| Z-1558-2015 | Class II | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Teleflex Medical | BTT | |
| Z-0269-2019 | Class I | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE... | OriGen Biomedical, Inc. | DWF | |
| Z-1923-2017 | Class II | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The... | Merge Healthcare Incorporated | DQK | |
| Z-0624-2016 | Class II | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and... | Nipro Medical Corporation | FJK |