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-1416-06 | Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref... | Zimmer GmbH | KWT | ||
| Z-0290-2007 | Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428... | Medtronic Neuromodulation | MHY | ||
| Z-0034-2008 | APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by... | Louisville Apl Diagnostics Inc | MID | ||
| Z-0192-2007 | UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4... | Plus Orthopedics | HRY | ||
| Z-0191-2007 | UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4... | Plus Orthopedics | HRY | ||
| Z-1443-06 | SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are... | Radiometer America, Inc | JKA | ||
| Z-0121-2007 | Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar... | Greatbatch Medical | DTB | ||
| Z-0120-2007 | Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6... | Greatbatch Medical | DTB | ||
| Z-1441-06 | Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization... | Diagnostica Stago, Inc. | GFO | ||
| Z-1486-06 | Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite. | Invacare GmbH | IOR | ||
| Z-1504-06 | Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog... | Therakos Inc | LNR | ||
| Z-1374-06 | Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and... | Roche Diagnostics GmbH | NPQ | ||
| Z-1373-06 | Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general... | Roche Diagnostics GmbH | NPQ | ||
| Z-1372-06 | Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose... | Roche Diagnostics GmbH | NPQ | ||
| Z-1481-06 | Regius Model 370 Digital Radiography Konica Minolta | Konica Minolta, Inc. | MQB | ||
| Z-1352-06 | Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models... | Roche Diagnostics GmbH | CEM | ||
| Z-0296-2008 | Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device... | Xoran Technologies, LLC | JAK | ||
| Z-1432-06 | Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766... | ConvaTec Limited | LNO | ||
| Z-1413-06 | Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. | Disetronic Medical Systems | LZG | ||
| Z-1431-06 | Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped... | Medtronic, Inc. | BSR | ||
| Z-0040-2007 | Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel... | Eagle Parts & Products, Inc. | ITI | ||
| Z-0039-2007 | Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel... | Eagle Parts & Products, Inc. | ITI | ||
| Z-1515-06 | Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA... | Porex Surgical, Inc. | LYA | ||
| Z-0479-2010 | Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8... | Cargille-Sacher Laboratories Inc. | JIX | ||
| Z-1401-06 | LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1430-06 | Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring... | Richard Wolf Medical Instruments Corp. | HIF | ||
| Z-0115-2007 | Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex... | Radiometer America, Inc | JQP | ||
| Z-1520-06 | OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E) | Oasis Medical, Inc. | LZU | ||
| Z-1409-06 | Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box... | FUJIFILM Healthcare Americas Corporation | MMY | ||
| Z-1353-06 | Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with... | Philips North America LLC | LLZ | ||
| Z-1256-06 | IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital... | AGFA Healthcare Corp. | LLZ | ||
| Z-1421-06 | Guardian 5 inch Walker Wheel Kits, Model Numbers: 07722-8, 07722G, 07722-5, 07722-8B... | Zhongshan A&e Machinery Industry Co., Ltd | ITJ | ||
| Z-1420-06 | Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry... | Zhongshan A&e Machinery Industry Co., Ltd | ITJ | ||
| Z-1405-06 | Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1300-06 | Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no... | Boston Scientific Corporation | KOG | ||
| Z-1195-06 | Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator... | MRL, Inc., A Welch Allyn Company | MJK | ||
| Z-1404-06 | Terumo Advanced Perfusion System 1 Roller Pump 4 inch diameter; Catalog No. 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1403-06 | Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1442-06 | SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be... | Radiometer America, Inc | GIO | ||
| Z-1410-06 | INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 | Mallinckrodt Manufacturing LLC | MRN | ||
| Z-0031-2007 | CR DX-S, Image Intensified Fluoroscopic X-ray system. | AGFA Healthcare Corp. | MQB | ||
| Z-1312-06 | OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus... | ArthroCare Corporation | KOG | ||
| Z-1451-06 | BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136 | Hardy Diagnostics | JSO | ||
| Z-0118-2007 | Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US... | Greatbatch Medical | DQY | ||
| Z-1384-06 | Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001... | Roche Diagnostics GmbH | LFR | ||
| Z-1383-06 | Accu-Chek Advantage Pro blood glucose test strips; International Reference no... | Roche Diagnostics GmbH | LFR | ||
| Z-1382-06 | Accu-Chek Advantage Plus blood glucose test strips; International Reference no... | Roche Diagnostics GmbH | LFR | ||
| Z-1381-06 | Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos... | Roche Diagnostics GmbH | LFR | ||
| Z-1380-06 | Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos... | Roche Diagnostics GmbH | LFR | ||
| Z-1379-06 | Accu-Chek Advantage II blood glucose test strips; International Reference nos... | Roche Diagnostics GmbH | LFR |