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-0284-2012 | Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0283-2012 | Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-1426-2013 | Class II | Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci... | Intuitive Surgical, Inc. | NAY | |
| Z-2259-2012 | Class II | UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2258-2012 | Class II | UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2257-2012 | Class II | UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0917-2012 | VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD... | Ortho-Clinical Diagnostics, Inc. | JIX | ||
| Z-0602-2012 | COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0601-2012 | Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0600-2012 | Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0599-2012 | Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0333-2012 | LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are... | Boston Scientific Corporation | LWS | ||
| Z-0167-2012 | Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number... | Advanced Medical Optics, Inc. | HNO | ||
| Z-0166-2012 | Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K... | Advanced Medical Optics, Inc. | HNO | ||
| Z-0165-2012 | Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K... | Advanced Medical Optics, Inc. | HNO | ||
| Z-0262-2012 | PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are... | GE Healthcare | KOY | ||
| Z-0304-2012 | Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A... | GE Healthcare | DXN | ||
| Z-0135-2012 | AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label... | Sierra Scientific Instruments, Inc. | FFX | ||
| Z-0183-2012 | Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary... | Albahealth, LLC | JOW | ||
| Z-2227-2012 | Class III | Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the... | Siemens Healthcare Diagnostics Inc. | CDP | |
| Z-1645-2012 | Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the... | Siemens Healthcare Diagnostics Inc. | MTG | ||
| Z-1796-2012 | Class II | Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft... | Integra LifeSciences Corporation | MQV | |
| Z-1795-2012 | Class II | Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute... | Integra LifeSciences Corporation | MQV | |
| Z-0830-2012 | Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL... | Mallinckrodt, Inc. | IZQ | ||
| Z-0847-2012 | Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for... | Lin-Zhi International Inc | DKB | ||
| Z-0188-2012 | PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads... | Alere San Diego, Inc. | LKB | ||
| Z-0365-2012 | Abbott m2000sp Instrument; an automated system for performing sample preparation for... | Abbott Molecular, Inc. | JJH | ||
| Z-0296-2012 | Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home... | Respironics, Inc. | CBK | ||
| Z-2444-2012 | Class II | SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1619-2012 | Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment... | Howmedica Osteonics Corp | LXH | ||
| Z-0381-2012 | UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic... | Integra LifeSciences Corporation | FST | ||
| Z-0380-2012 | Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage... | Integra LifeSciences Corporation | FST | ||
| Z-0379-2012 | Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic... | Integra LifeSciences Corporation | FST | ||
| Z-0378-2012 | Luxtec UltraLite Headlight System sweatband with short linkage Model... | Integra LifeSciences Corporation | FST | ||
| Z-0377-2012 | Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber... | Integra LifeSciences Corporation | FST | ||
| Z-0376-2012 | Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage... | Integra LifeSciences Corporation | FST | ||
| Z-0375-2012 | Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber... | Integra LifeSciences Corporation | FST | ||
| Z-0374-2012 | Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model... | Integra LifeSciences Corporation | FST | ||
| Z-0373-2012 | Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage... | Integra LifeSciences Corporation | FST | ||
| Z-0203-2012 | EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II... | Meridian Bioscience Inc | LFX | ||
| Z-1009-2012 | BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of... | Becton Dickinson & Co | FMI | ||
| Z-1101-2012 | Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL... | Capitol Vial Inc | JKA | ||
| Z-0986-2012 | Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined... | Integra LifeSciences Corporation | MQV | ||
| Z-0845-2012 | Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big... | Philips North America LLC | JAK | ||
| Z-0392-2012 | Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI... | Surgical Appliance Industries, Inc. | FQL | ||
| Z-0391-2012 | Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform... | Surgical Appliance Industries, Inc. | FQL | ||
| Z-0168-2012 | SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer... | Merit Medical Systems, Inc. | DYB | ||
| Z-0162-2012 | ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay... | Abbott Medical | MKW | ||
| Z-0294-2012 | Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital... | Pelstar, LLC | FRI | ||
| Z-1881-2017 | Class II | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software... | Zimmer CAS | OLO |