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-2348-2012 | Class II | Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-0164-2010 | Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment. | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0163-2010 | Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging Equipment. | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0162-2010 | Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment. | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0147-2010 | Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03... | Abbott Medical | dxg | ||
| Z-0146-2010 | Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01... | Abbott Medical | dxg | ||
| Z-0145-2010 | Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01... | Abbott Medical | dxg | ||
| Z-0144-2010 | Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord... | Abbott Medical | dxg | ||
| Z-0143-2010 | Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO... | Abbott Medical | dxg | ||
| Z-0142-2010 | Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord... | Abbott Medical | dxg | ||
| Z-0034-2010 | Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05, 11855-04-07; AC cord... | Abbott Medical | FRN | ||
| Z-0033-2010 | Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07; AC cord manufactured by... | Abbott Medical | FRN | ||
| Z-0032-2010 | Plum XL3M, List numbers 11845-04-03, 11845-04-05, 11845-04-07, 11845-04-11, 11845-04-13... | Abbott Medical | FRN | ||
| Z-0031-2010 | Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by... | Abbott Medical | FRN | ||
| Z-0030-2010 | Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09... | Abbott Medical | FRN | ||
| Z-0029-1010 | Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC cord manufactured by... | Abbott Medical | FRN | ||
| Z-0028-2010 | Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03... | Abbott Medical | FRN | ||
| Z-0027-2010 | Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03... | Abbott Medical | FRN | ||
| Z-0026-2010 | Plum A+3 v.11.X, list #s 12618-04-01, 12918-04-03, 12618-04-05, 12618-04-51, 12618-04-07... | Abbott Medical | FRN | ||
| Z-0025-2010 | Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05, 11971-04-07, 11971-04-51... | Abbott Medical | FRN | ||
| Z-0024-2010 | Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51... | Abbott Medical | FRN | ||
| Z-0023-2010 | Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07, 12348-04-51; AC cord... | Abbott Medical | FRN | ||
| Z-0022-2010 | Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC... | Abbott Medical | FRN | ||
| Z-0021-2010 | Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC cord... | Abbott Medical | FRN | ||
| Z-0020-2010 | Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC... | Abbott Medical | FRN | ||
| Z-0019-2010 | Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03, 11365-04-05; AC cord... | Abbott Medical | FRN | ||
| Z-0018-2010 | LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51... | Abbott Medical | FRN | ||
| Z-0017-2010 | LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09... | Abbott Medical | FRN | ||
| Z-0016-2010 | LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord... | Abbott Medical | FRN | ||
| Z-0015-2010 | GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03... | Abbott Medical | FRN | ||
| Z-0014-2010 | GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01, AC cord... | Abbott Medical | FRN | ||
| Z-0013-2010 | Flexiflo Quantum Enteral Pump, List number 50596, AC cord manufactured by Electri-Cord... | Abbott Medical | FRN | ||
| Z-0012-2010 | Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51... | Abbott Medical | FRN | ||
| Z-0011-2010 | AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the... | Abbott Medical | FRN | ||
| Z-1174-2012 | Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code... | Siemens Healthcare Diagnostics Inc. | DKB | ||
| Z-1173-2012 | Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product... | Siemens Healthcare Diagnostics Inc. | DLZ | ||
| Z-0965-2012 | Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external... | Ossur Iceland ehf. | ISY | ||
| Z-0060-2010 | Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model... | Western Enterprises, Inc. | CAN | ||
| Z-0061-2010 | Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model... | Western Enterprises, Inc. | CAN | ||
| Z-0059-2010 | Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device... | Western Enterprises, Inc. | CAN | ||
| Z-2243-2009 | TomoTherapy Hi-Art System, Version 3.X ThomoTherapy Incorporated 1240 Deming Way... | Accuray Incorporated | MUJ | ||
| Z-0285-2010 | Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 737 (also known... | Stryker Medical | FPO | ||
| Z-0284-2010 | Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 736. Wheeled... | Stryker Medical | FPO | ||
| Z-0283-2010 | Stryker Medical cam bearing service parts, Stryker Medical, Portage, MI; Parts... | Stryker Medical | FPO | ||
| Z-2218-2009 | Stryker MedSurg bed, 115v, Stryker Medical, Portage, MI; Model 3002 S3. Beds are A/C... | Stryker Medical | FNL | ||
| Z-2217-2009 | Stryker Secure II MedSurg bed, 230 v, Stryker Medical, Portage, MI; Model 3221. (Note... | Stryker Medical | FNL | ||
| Z-2216-2009 | Stryker Secure II MedSurg bed, 115 v, Stryker Medical, Portage, MI; Model 3002. Beds... | Stryker Medical | FNL | ||
| Z-2215-2009 | Stryker Zoom critical care bed, 115v, Stryker Medical, Portage, MI; Model 2040. Beds... | Stryker Medical | FNL | ||
| Z-2214-2009 | Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031... | Stryker Medical | FNL | ||
| Z-0282-2010 | Stryker Medical , Model 722. Wheeled hospital stretcher. | Stryker Medical | FPO |