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-0469-06 | AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for... | Possis Medical, Inc. | DXE | ||
| Z-0392-06 | Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH... | Medtronic Gastroenterology / Urology | FFT | ||
| Z-0358-06 | Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic... | Philips North America LLC | LNH | ||
| Z-0363-06 | Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001. | Roche Diagnostics GmbH | CGA | ||
| Z-0362-06 | Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001. | Roche Diagnostics GmbH | CGA | ||
| Z-0361-06 | Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001. | Roche Diagnostics GmbH | KHG | ||
| Z-0660-06 | Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large... | Abbott Medical | FPA | ||
| Z-0659-06 | Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large... | Abbott Medical | FPA | ||
| Z-0658-06 | Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large... | Abbott Medical | FPA | ||
| Z-0398-06 | ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed... | Abbott Medical | JJE | ||
| Z-0377-06 | Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package... | Boston Scientific Corporation | BTG | ||
| Z-0376-06 | Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm... | Boston Scientific Corporation | BTG | ||
| Z-0410-06 | The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon... | Boston Scientific Corporation | LIT | ||
| Z-0437-06 | Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. | Datascope Corp. | MHX | ||
| Z-0382-06 | Roche Elecsys total PSA CalSet, catalog number 11731696322. | Roche Diagnostics GmbH | LTJ | ||
| Z-0381-06 | Roche Elecsys total PSA, catalog number 11731262322. | Roche Diagnostics GmbH | LTJ | ||
| Z-0409-06 | The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes... | Boston Scientific Corporation | MCX | ||
| Z-0436-06 | Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified... | Abbott Medical | BTL | ||
| Z-0397-06 | VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A... | Plus Orthopedics | JWH | ||
| Z-0434-06 | Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A)... | Tnco, Inc. | GCK | ||
| Z-0280-06 | Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For... | Boston Scientific Corporation | DTK | ||
| Z-0605-2011 | Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin... | Zimmer GmbH | KWQ | ||
| Z-0604-2011 | Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX... | Zimmer GmbH | KWQ | ||
| Z-0603-2011 | Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF... | Zimmer GmbH | KWQ | ||
| Z-0602-2011 | Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX... | Zimmer GmbH | KWQ | ||
| Z-0429-06 | The AIRIS II MR System is an imaging device and is intended to provide the physician with... | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0372-06 | BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder. | Becton Dickinson & Co | KSR | ||
| Z-0430-06 | BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0... | Becton Dickinson & Co | JQX | ||
| Z-0503-06 | AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with... | Teleflex Medical | BTT | ||
| Z-0428-06 | The AIRIS MR System is an imaging device and is intended to provide the physician with... | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0375-06 | Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for... | Kimberly-Clark Corporation | BSY | ||
| Z-0374-06 | Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with... | Kimberly-Clark Corporation | BSY | ||
| Z-0373-06 | Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only *... | Kimberly-Clark Corporation | BSY | ||
| Z-0335-06 | 3D TOP Ceiling Stand. X-Ray System model number 8773673 | Siemens Medical Solutions USA, Inc. | IYB | ||
| Z-0370-06 | Medtronic Activa Deep Brain Stimulation (DBS) system including the following system... | Medtronic Neuromodulation | MHY | ||
| Z-0323-06 | 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by... | WNCK, Inc | DJZ | ||
| Z-0539-06 | Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for... | Medtronic, Inc. | DXY | ||
| Z-0906-06 | Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2... | Laboratorios Grifols, S.A. | KPE | ||
| Z-0538-06 | Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker... | Medtronic, Inc. | DXY | ||
| Z-0537-06 | Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106... | Medtronic, Inc. | DXY | ||
| Z-0536-06 | Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular... | Medtronic, Inc. | DXY | ||
| Z-0535-06 | Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models... | Medtronic, Inc. | DXY | ||
| Z-0534-06 | Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 | Medtronic, Inc. | DXY | ||
| Z-0334-06 | Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-0575-06 | The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin... | Gish Biomedical, Inc. | DTZ | ||
| Z-0519-06 | The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating)... | Gish Biomedical, Inc. | DTZ | ||
| Z-0431-06 | Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical... | Integra LifeSciences Corporation | LFL | ||
| Z-0330-06 | Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482 | Medtronic Sofamor Danek Instrument Manufacturing | HXX | ||
| Z-0333-06 | Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-0380-06 | Cytomics FC500 with CXP Software | Siemens Healthcare Diagnostics Inc. | JJF |