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-0346-2017 | Class II | Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology... | Stryker Corp. | DQY | |
| Z-0345-2017 | Class II | Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology... | Stryker Corp. | DQY | |
| Z-0344-2017 | Class II | Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0343-2017 | Class II | Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0342-2017 | Class II | Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology... | Stryker Corp. | DQY | |
| Z-0341-2017 | Class II | Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0340-2017 | Class II | Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology... | Stryker Corp. | DQY | |
| Z-0339-2017 | Class II | Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0338-2017 | Class II | Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology... | Stryker Corp. | DQY | |
| Z-0337-2017 | Class II | Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0336-2017 | Class II | Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0335-2017 | Class II | Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0334-2017 | Class II | Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston... | Stryker Corp. | DQY | |
| Z-0333-2017 | Class II | Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology... | Stryker Corp. | DQY | |
| Z-0310-2017 | Class I | X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0... | Medtronic, Inc. | DQX | |
| Z-0309-2017 | Class I | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro... | Medtronic, Inc. | KRA | |
| Z-0308-2017 | Class I | Alligator Retrieval Device The device is intended for use in the peripheral and... | Medtronic, Inc. | DQY | |
| Z-0398-2017 | Class II | Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test) | Siemens Healthcare Diagnostics Inc. | MRG | |
| Z-0397-2017 | Class II | Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) | Siemens Healthcare Diagnostics Inc. | MRG | |
| Z-0390-2017 | Class II | Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of... | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-0746-2017 | Class II | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is... | STERIS Corporation | FTD | |
| Z-0600-2017 | Class II | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box)... | C.R. Bard Inc | MJC | |
| Z-0307-2017 | Class I | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the... | Medtronic, Inc. | OUT | |
| Z-0592-2017 | Class II | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The... | Alphatec Spine, Inc. | NKB | |
| Z-0587-2017 | Class II | FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate... | Inpeco S.p.A. | CEM | |
| Z-0890-2017 | Class II | Best Practices kits containing certain production lots of Clearify Visualization... | Medtronic, Inc. | FEI | |
| Z-0396-2017 | Class II | COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number... | Roche Diagnostics GmbH | PDJ | |
| Z-0395-2017 | Class II | Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 /... | Roche Diagnostics GmbH | LCP | |
| Z-0926-2017 | Class I | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and... | Nurse Assist, LLC | NGT | |
| Z-0889-2017 | Class II | Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to... | Medtronic, Inc. | FEI | |
| Z-0369-2017 | Class II | TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that... | Medimaps Group SA | KGI | |
| Z-0644-2017 | Class II | 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile | Synthes (USA) Products LLC | HTO | |
| Z-0643-2017 | Class II | 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile | Synthes (USA) Products LLC | HTO | |
| Z-0642-2017 | Class II | Extraction Hook - Sterile for TI Cannulated Nails | Synthes (USA) Products LLC | LXH | |
| Z-0641-2017 | Class II | 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile | Synthes (USA) Products LLC | HTO | |
| Z-0640-2017 | Class II | 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile | Synthes (USA) Products LLC | HTO | |
| Z-0639-2017 | Class II | 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile | Synthes (USA) Products LLC | HSB | |
| Z-0638-2017 | Class II | 3.0 mm Reaming Rod/950 mm, Sterile | Synthes (USA) Products LLC | HTO | |
| Z-0637-2017 | Class II | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile | Synthes (USA) Products LLC | HTO | |
| Z-0788-2017 | Class I | Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model... | Medtronic Neuromodulation | LKK | |
| Z-0700-2017 | Class II | Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device... | Medtronic Neuromodulation | MHY | |
| Z-0304-2017 | Class II | 4205 Journey Rolling Walker Product Usage: used to assist people in walking | Nova Ortho-Med Inc | ITJ | |
| Z-0732-2017 | Class II | Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed... | GF Health Products, Inc. | FNL | |
| Z-0400-2017 | Class II | PET Infusion Pump | Medrad, Inc. | FRN | |
| Z-1193-2017 | Class II | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is... | Mako Surgical Corp. | OLO | |
| Z-0413-2017 | Class II | The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to... | LivaNova USA, Inc. | KRG | |
| Z-0412-2017 | Class II | The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to... | LivaNova USA, Inc. | KRG | |
| Z-0328-2017 | Class I | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in... | Sentreheart, Inc. | DQX | |
| Z-1690-2017 | Class II | 8500M Handheld Pulse Oximeter | Nonin Medical, Inc | DQA | |
| Z-0591-2017 | Class II | FlexLab Automation Modules | Siemens Healthcare Diagnostics Inc. | JJE |