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-1530-2008 | BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-1038-2008 | Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0731-2008 | Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360... | Eastman Kodak Company | KPR | ||
| Z-0932-2008 | Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100... | Medrad, Inc. | LFR | ||
| Z-0931-2008 | Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips... | Medrad, Inc. | LFR | ||
| Z-1372-2008 | Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01... | GE Healthcare | KKX | ||
| Z-1102-2008 | Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. | Seradyn, Inc. | LEH | ||
| Z-0587-2008 | Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0... | Myelotec, Inc. | HRX | ||
| Z-0586-2008 | Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and... | Myelotec, Inc. | HRX | ||
| Z-0880-2008 | Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of... | Spinal Concepts, Inc. | GZT | ||
| Z-1103-2008 | White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire... | Abbott Medical | GGK | ||
| Z-1136-2008 | BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by... | Arjo, Inc. | FRW | ||
| Z-1135-2008 | BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by... | Arjo, Inc. | FRW | ||
| Z-1565-2008 | GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote... | GE Healthcare | JAA | ||
| Z-1564-2008 | GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F... | GE Healthcare | JAA | ||
| Z-1563-2008 | GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote... | GE Healthcare | JAA | ||
| Z-1317-2008 | LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for... | Lifescan, Inc. | NBW | ||
| Z-0668-2008 | Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System... | Howmedica Osteonics Corp | JDI | ||
| Z-0585-2008 | Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840... | Lumenis Ltd | GEX | ||
| Z-0865-2008 | Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package... | Zimmer Surgical SA | FQH | ||
| Z-0864-2008 | Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-495-00... | Zimmer Surgical SA | FQH | ||
| Z-0863-2008 | Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic... | Zimmer Surgical SA | FQH | ||
| Z-0862-2008 | Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical... | Zimmer Surgical SA | FQH | ||
| Z-0861-2008 | Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10... | Zimmer Surgical SA | FQH | ||
| Z-0860-2008 | Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer... | Zimmer Surgical SA | FQH | ||
| Z-0859-2008 | Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic... | Zimmer Surgical SA | FQH | ||
| Z-0858-2008 | Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10... | Zimmer Surgical SA | FQH | ||
| Z-0857-2008 | Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer... | Zimmer Surgical SA | FQH | ||
| Z-0856-2008 | Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10... | Zimmer Surgical SA | FQH | ||
| Z-2235-2008 | NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a... | Neusoft Medical Systems Co., Ltd. | JAK | ||
| Z-2178-2008 | Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10... | Cook Vandergrift, Inc. | MQH | ||
| Z-1134-2008 | GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number... | GE Healthcare | KPR | ||
| Z-1133-2008 | GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers... | GE Healthcare | KPR | ||
| Z-0986-2008 | VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) | ZOLL Palm Springs | CBK | ||
| Z-0985-2008 | VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) | ZOLL Palm Springs | CBK | ||
| Z-0984-2008 | VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) | ZOLL Palm Springs | CBK | ||
| Z-0983-2008 | VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) | ZOLL Palm Springs | CBK | ||
| Z-1232-2008 | INTELECT MOBILE, Model No. 2777, Chattanooga Group, Hixson, TN 37343, Made in the USA... | Chattanooga Corp Inc | MPH | ||
| Z-1231-2008 | INTELECT MOBILE COMBO, Model No. 2778, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1230-2008 | INTELECT ADVANCED STIM, Model No. 2773MS, Chattanooga Group, Hixson, TN 37343, Made in... | Chattanooga Corp Inc | MPH | ||
| Z-1229-2008 | INTELECT ADVANCED, Model No. 2772MC, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1228-2008 | INTELECT ADVANCED, Model No. 2765CS, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1227-2008 | INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1226-2008 | INTELECT ADVANCED, Model No. 2755CS, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1225-2008 | INTELECT ADVANCED, Model No. 2752CC, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1224-2008 | INTELECT VET, Model No. 2843, Chattanooga Group, Hixson, TN 37343, Made in the USA | Chattanooga Corp Inc | MPH | ||
| Z-1223-2008 | INTELECT VET, Model No. 2756, Chattanooga Group, Hixson, TN 37343, Made in the USA | Chattanooga Corp Inc | MPH | ||
| Z-1222-2008 | VECTRA TRANSPORTABLE, Model No. 2783, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-1221-2008 | VECTRA GENISYS, Model No. 2764, Chattanooga Group, Hixson, TN 37343, Made in the USA | Chattanooga Corp Inc | MPH | ||
| Z-1220-2008 | VECTRA GENISYS, Model No. 2761, Chattanooga Group, Hixson, TN 37343, Made in the USA | Chattanooga Corp Inc | MPH |