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-1541-2009 | i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for... | Abbott Medical | CHL | ||
| Z-1154-2009 | Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights... | Maquet Cardiovascular Us Sales, LLC | FTD | ||
| Z-1153-2009 | ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights... | Maquet Cardiovascular Us Sales, LLC | FTD | ||
| Z-1540-2009 | i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode... | Abbott Medical | CHL | ||
| Z-0975-2010 | PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer... | Polymer Technology Systems | CHH | ||
| Z-0150-2010 | ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM... | Sendx Medical, Inc. | CHL | ||
| Z-2222-2009 | Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM... | Abbott Medical | LOJ | ||
| Z-0643-2010 | BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes... | Becton Dickinson & Co | KZI | ||
| Z-2437-2010 | SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX... | Siemens Healthcare Diagnostics Inc. | LCD | ||
| Z-0169-2010 | Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows... | Biomet Microfixation | LXH | ||
| Z-1580-2009 | TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model #... | Philips North America LLC | KPS | ||
| Z-1579-2009 | TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is... | Philips North America LLC | KPS | ||
| Z-1578-2009 | TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on... | Philips North America LLC | JAK | ||
| Z-1155-2009 | GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System | GE Healthcare | JAA | ||
| Z-1208-2009 | Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant... | Wright Medical Technology Inc | LXH | ||
| Z-2317-2009 | AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories... | Abbott Medical | JJE | ||
| Z-1949-2009 | BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP... | Biomet Microfixation | EJL | ||
| Z-0035-2010 | WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold... | Gentherm Medical, LLC | DWJ | ||
| Z-1171-2009 | Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use... | Physio Control, Inc. | LDD | ||
| Z-1156-2009 | NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA... | Abbott Medical | DQK | ||
| Z-1061-2009 | Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN... | Zimmer GmbH | JDW | ||
| Z-1136-2012 | Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210... | Ormco/Sybronendo | EJF | ||
| Z-1152-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J... | Medtronic Neurosurgery | JXG | ||
| Z-1151-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H... | Medtronic Neurosurgery | JXG | ||
| Z-1150-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G... | Medtronic Neurosurgery | JXG | ||
| Z-1149-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F... | Medtronic Neurosurgery | JXG | ||
| Z-1148-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E... | Medtronic Neurosurgery | JXG | ||
| Z-1147-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D... | Medtronic Neurosurgery | JXG | ||
| Z-1146-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C... | Medtronic Neurosurgery | JXG | ||
| Z-1145-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B... | Medtronic Neurosurgery | JXG | ||
| Z-1144-2009 | Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A... | Medtronic Neurosurgery | JXG | ||
| Z-1143-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1142-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each... | Medtronic Neurosurgery | JXG | ||
| Z-1141-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1140-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1139-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1138-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1137-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1136-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1135-2009 | Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter... | Medtronic Neurosurgery | JXG | ||
| Z-1134-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A... | Medtronic Neurosurgery | JXG | ||
| Z-1133-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B... | Medtronic Neurosurgery | JXG | ||
| Z-1132-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C... | Medtronic Neurosurgery | JXG | ||
| Z-1131-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D... | Medtronic Neurosurgery | JXG | ||
| Z-1130-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E... | Medtronic Neurosurgery | JXG | ||
| Z-1129-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F... | Medtronic Neurosurgery | JXG | ||
| Z-1128-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G... | Medtronic Neurosurgery | JXG | ||
| Z-1127-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H... | Medtronic Neurosurgery | JXG | ||
| Z-1126-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J... | Medtronic Neurosurgery | JXG | ||
| Z-1125-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K... | Medtronic Neurosurgery | JXG |