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-0958-03 | I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion... | Abbott Medical | FRN | ||
| Z-0957-03 | Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott... | Abbott Medical | FPA | ||
| Z-0956-03 | I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago... | Abbott Medical | FPA | ||
| Z-0174-04 | Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak. | Invacare GmbH | LLI | ||
| Z-0955-03 | Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single... | Abbott Medical | FPA | ||
| Z-0583-05 | KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic... | KCI USA, Inc. | IOQ | ||
| Z-1150-04 | IMMAGE IgM Reagent Part No.: 447610 | Siemens Healthcare Diagnostics Inc. | DEW | ||
| Z-1147-04 | IMMAGE IGMLC Reagent Part Number: 447470 | Siemens Healthcare Diagnostics Inc. | CFN | ||
| Z-1146-04 | IMMAGE IGALC Reagent Part Number: 447460 | Siemens Healthcare Diagnostics Inc. | CFN | ||
| Z-0981-03 | A.R.C. Laser Photolysis Probe/Handpiece | A.R.C. Laser GmbH | GEX | ||
| Z-0968-03 | Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 | Greatbatch Medical | DYB | ||
| Z-0967-03 | Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part... | Greatbatch Medical | DYB | ||
| Z-0966-03 | AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog... | Greatbatch Medical | DYB | ||
| Z-0965-03 | AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog... | Greatbatch Medical | DYB | ||
| Z-0964-03 | AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog... | Greatbatch Medical | DYB | ||
| Z-0963-03 | Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 | Greatbatch Medical | DYB | ||
| Z-0962-03 | Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011 | Greatbatch Medical | DYB | ||
| Z-1149-03 | ABX Diagnostices Pentra 60C+ Hematology Analyzer | Horiba Instruments Incorporated | GKZ | ||
| Z-0944-03 | Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental... | Safco Dental Supply LLC | FXX | ||
| Z-0974-03 | Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3 | CliniSys, Inc | JQP | ||
| Z-0953-03 | Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1 | Allen Medical Systems, Inc. | FWZ | ||
| Z-0942-03 | Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product... | Medtronic, Inc. | KNW | ||
| Z-0921-03 | Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away... | Stryker Corp. | |||
| Z-1215-03 | Triton MP-1 Traction Unit | Chattanooga Corp Inc | INW | ||
| Z-1210-03 | Triton T-700 Traction Unit, | Chattanooga Corp Inc | ITF | ||
| Z-1132-03 | Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of... | Abbott Medical | CEC | ||
| Z-1131-03 | IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL... | Abbott Medical | CEC | ||
| Z-1130-03 | Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M... | Abbott Medical | CEC | ||
| Z-0971-03 | Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. | Revvity Health Sciences, Inc. | JIA | ||
| Z-0970-03 | Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays. | Revvity Health Sciences, Inc. | JIA | ||
| Z-0969-03 | Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays. | Revvity Health Sciences, Inc. | JIA | ||
| Z-0395-05 | Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series... | Baxter Healthcare Renal Div | FKP | ||
| Z-0848-04 | Axiom Artis System | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0952-03 | Exradin A12 Ionization Chamber | Standard Imaging Inc. | IYE | ||
| Z-0948-03 | StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | ||
| Z-0100-04 | Digital Fluorographic System model DFP-2000A. | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1001-03 | MagNA Pure LC Instrument; Catalog number 2236931. | Roche Diagnostics GmbH | |||
| Z-0554-04 | SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST | Scion Cardio-Vascular, Inc. | FGO | ||
| Z-1002-03 | Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and... | Coapt Systems, Inc. | --- | ||
| Z-1037-03 | Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes | Quest Medical, Inc | DWF | ||
| Z-0939-03 | CryoValve Pulmonary Valve & Conduit. | Artivion, Inc. | MIE | ||
| Z-0938-03 | CryoValve Pulmonary Valve & Conduit. | Artivion, Inc. | MIE | ||
| Z-0940-03 | LIFEPAK CR Plus defibrillator | Physio Control, Inc. | MKJ | ||
| Z-0931-03 | Line Powered RePak, Model Number 1785S | Rehabilicare, Inc. | GZJ | ||
| Z-0418-05 | Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' 11... | Teleflex Medical | GDO | ||
| Z-1291-03 | GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is... | GE Medical Systems Information Technologies, Inc. | HGM | ||
| Z-0986-03 | Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples... | Ethicon Endo-Surgery Inc | MDM | ||
| Z-0985-03 | Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples... | Ethicon Endo-Surgery Inc | MDM | ||
| Z-1148-04 | Synchron Systems Prealbumin Reagent Part Number: 475106 | Siemens Healthcare Diagnostics Inc. | JIS | ||
| Z-1272-02 | Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020 | Dentalez, Inc., Stardental Division |