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-1550-06 | Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche... | Roche Diagnostics GmbH | CGN | ||
| Z-1985-2012 | Class I | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System... | GE Healthcare | LLZ | |
| Z-0057-2007 | Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. | Depuy Orthopaedics Inc. | JWH | ||
| Z-0178-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. | Michigan Instruments | DRM | ||
| Z-0242-2007 | Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0241-2007 | Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0240-2007 | Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0239-2007 | Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0238-2007 | Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0237-2007 | Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0236-2007 | Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0235-2007 | Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0234-2007 | Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0233-2007 | Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0041-2007 | GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems... | GE Healthcare | JAA | ||
| Z-0020-07 | CSI Toric, soft (hydrophilic) contact lenses | Alcon Laboratories | LPL | ||
| Z-0019-07 | CSI Flexible Wear, soft (hydrophilic) contact lenses | Alcon Laboratories | LPL | ||
| Z-0018-07 | CSI Daily Wear, soft (hydrophilic) contact lenses | Alcon Laboratories | LPL | ||
| Z-0340-2007 | Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this... | Medtronic Perfusion Systems | DWE | ||
| Z-0566-2007 | Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0043-2007 | Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 | Bioplate Inc | JEY | ||
| Z-0291-2007 | Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF... | GE Healthcare | BSZ | ||
| Z-0487-2007 | GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA. | Varian Medical Systems, Inc. | JAQ | ||
| Z-0486-2007 | GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0051-2007 | Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle... | Medtronic, Inc. | FMF | ||
| Z-0936-2009 | Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number... | Howmedica Osteonics Corp | MDM | ||
| Z-0353-2007 | ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | LEG | ||
| Z-0352-2007 | ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | LEG | ||
| Z-0351-2007 | ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | LEG | ||
| Z-0253-2007 | BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample... | Becton Dickinson & Co | JKA | ||
| Z-0117-2007 | Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 | Abbott Diagnostic International, Ltd. | JJE | ||
| Z-0008-2007 | Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800... | Stryker Corp. | HAW | ||
| Z-0007-2007 | Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010... | Stryker Corp. | HAW | ||
| Z-0006-2007 | Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800... | Stryker Corp. | HAW | ||
| Z-1542-06 | Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST... | Micrus Endovascular Corporation | DQX | ||
| Z-0005-2007 | Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker #... | Stryker Corp. | HAW | ||
| Z-0025-2007 | Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use. | Abbott Diagnostic International, Ltd. | JIT | ||
| Z-0024-2007 | FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. | Abbott Diagnostic International, Ltd. | JIT | ||
| Z-0023-2007 | Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. | Abbott Diagnostic International, Ltd. | JIS | ||
| Z-0124-2007 | Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of... | Hydrocision, Inc. | HRX | ||
| Z-0123-2007 | HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of... | Hydrocision, Inc. | HRX | ||
| Z-0536-2007 | Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252 | Sekisui Diagnostics P.E.I. Inc. | JIX | ||
| Z-0181-2007 | VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless... | Ebi, LLC | KTT | ||
| Z-0180-2007 | VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx... | Ebi, LLC | KTT | ||
| Z-0169-2007 | Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare... | Baxter Healthcare Renal Div | KDI | ||
| Z-0986-2009 | Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I... | Howmedica Osteonics Corp | MNI | ||
| Z-0228-2007 | VerifyNow P2Y12 Assay Device Kit, Part Number 85054 | Accumetrics, Inc. | JOZ | ||
| Z-0072-2007 | Sienet Magic View 300, picture archiving and communications system. Model numbers... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0071-2007 | Sienet Sky, picture archiving and communications system. Model number 8463163 | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0070-2007 | syngo Imaging, picture archiving and communications system. Model number 7502029 | Siemens Medical Solutions USA, Inc. | LLZ |