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-1451-04 | DANA Diabecare II insulin pumps | Dana Diabecare USA LLC | LZG | ||
| Z-1003-04 | Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single... | Wilson-Cook Medical Inc. | FPD | ||
| Z-1112-05 | PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV... | Boston Scientific Corporation | LJS | ||
| Z-0704-05 | DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of... | Diasorin Inc. | CIZ | ||
| Z-1009-04 | Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt | LivaNova USA, Inc. | DTN | ||
| Z-1020-04 | Radionics Head and Neck Localilizer (HNL), Version B | Radionics, Inc. | MUJ | ||
| Z-0433-06 | Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide... | Boston Scientific Corporation | DQY | ||
| Z-0432-06 | Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide... | Boston Scientific Corporation | DQY | ||
| Z-1120-04 | COBAS TaqMan 48 Analyzers. | Roche Molecular Systems Inc | JJF | ||
| Z-1119-04 | COBAS TaqMan Analyzer | Roche Molecular Systems Inc | JJF | ||
| Z-1023-04 | Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 | Cas Medical Systems, Inc. | BZQ | ||
| Z-1013-04 | HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for... | Baxter Healthcare Renal Div | FKX-- | ||
| Z-1012-04 | HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter... | Baxter Healthcare Renal Div | FKX-- | ||
| Z-1034-04 | Power Heart Automatic External Defibrillator, Model 9210 RD | ZOLL Medical Corporation | MKJ | ||
| Z-1033-04 | Power Heart AED Automatic External Defibrillator, Model 9200 RD | ZOLL Medical Corporation | MKJ | ||
| Z-1035-04 | Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless... | Straumann USA, LLC | DZE | ||
| Z-1094-04 | Fischer SenoScan True View Digital Mammography System. | Fischer Imaging Corp. | MUE | ||
| Z-1014-04 | Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of... | Zimmer Spine, Inc. | HWX | ||
| Z-1006-04 | Quickcable Autoclaveable Cable Electrode Cable | Biosense Webster Inc | DRF | ||
| Z-0703-05 | Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50... | Diasorin Inc. | JTC | ||
| Z-1032-04 | Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. | Sechrist Industries Inc | CBK | ||
| Z-1232-04 | Boehringer Replacement Gauge Model 9071, Lot Number 200405. | Boehringer Laboratories, LLC | GCX | ||
| Z-1231-04 | Boheringer Suction Regulator Model 7702L, Lot number 04D Boehinger Replacement Gauge... | Boehringer Laboratories, LLC | GCX | ||
| Z-1002-04 | AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management... | Acist Medical Systems, Inc. | DXT | ||
| Z-1017-04 | Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080 | Abbott Medical | JOH | ||
| Z-1016-04 | Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070 | Abbott Medical | JOH | ||
| Z-0995-04 | LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with... | Lumend, Inc. | DQY | ||
| Z-1446-04 | AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-1228-04 | Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and... | Roche Diagnostics GmbH | LZG | ||
| Z-1227-04 | Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and... | Roche Diagnostics GmbH | LZG | ||
| Z-1226-04 | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C... | Roche Diagnostics GmbH | LZG | ||
| Z-1225-04 | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C... | Roche Diagnostics GmbH | LZG | ||
| Z-1224-04 | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C... | Roche Diagnostics GmbH | LZG | ||
| Z-1223-04 | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C... | Roche Diagnostics GmbH | LZG | ||
| Z-1222-04 | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C... | Roche Diagnostics GmbH | LZG | ||
| Z-0440-06 | Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire... | Boston Scientific Corporation | FGE | ||
| Z-0648-05 | Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml... | Teleflex Medical | KNX | ||
| Z-0647-05 | Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml... | Teleflex Medical | KNX | ||
| Z-1028-04 | Trolley for Intera/NT MRI System | Philips North America LLC | LNH | ||
| Z-0639-2007 | CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured... | Abbott Medical | GIF | ||
| Z-1089-04 | The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and... | Vascular Solutions LLC | DXE | ||
| Z-1040-04 | Synchromed II infusion pump | Medtronic Neuromodulation | FRN | ||
| Z-1077-04 | GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant... | Abbott Labs | FRN | ||
| Z-1018-04 | VerifyNow Asprin Assay Kit Part No. 85034 | Accumetrics, Inc. | JOZ | ||
| Z-1011-04 | 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by... | Encore Medical, LP | JWH | ||
| Z-1010-04 | Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore... | Encore Medical, LP | JWH | ||
| Z-0951-04 | 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for... | Dynarex Corp. | FQM | ||
| Z-0389-04 | Lodox Statscan digital radiographic system. | Lodox Na LLC | |||
| Z-1335-04 | Amigo Insulin Infusion Pump | Nipro Diabetes Systems, Inc. | LZG | ||
| Z-1005-04 | Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software... | FUJIFILM Healthcare Americas Corporation | ITX |