510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,476 records, page 905 of 1190
FDA device recalls, page 905 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1608-2010Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture...Ethicon, IncGAM
Z-1003-2011Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product...Varian Medical Systems, Inc.IYE
Z-1760-2010Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide...Boston Scientific CorporationDQX
Z-1616-2010Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers...FUJIFILM Healthcare Americas CorporationMOS
Z-0922-2011Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K...Stryker Corp.GCJ
Z-2353-2010CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara...Abbott MedicalGKZ
Z-2352-2010CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA...Abbott MedicalGKZ
Z-2351-2010CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa...Abbott MedicalGKZ
Z-2350-2010CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa...Abbott MedicalGKZ
Z-1754-2010Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and...Continental Medical Labs,IncCAH
Z-1635-2010Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton...Ferring Pharmaceuticals IncMOZ
Z-0610-2011NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog #...Zimmer GmbHLXH
Z-0609-2011NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00...Zimmer GmbHLXH
Z-2349-2010Picasso/Picasso Lite lasers Intended use: Dentistry.Cao Group, Inc.GEX
Z-1974-2010Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB...Change Healthcare Technologies LLCDQK
Z-1645-2010Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers...STRYKER Communications, Inc.BRY
Z-1644-2010SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230...STRYKER Communications, Inc.GCJ
Z-1643-2010SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and...STRYKER Communications, Inc.GCJ
Z-1642-2010Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number...STRYKER Communications, Inc.FSY
Z-1641-2010Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number...STRYKER Communications, Inc.FSY
Z-1640-2010Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers...STRYKER Communications, Inc.FSY
Z-1786-2010directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.Accriva Diagnostics, Inc.GGN
Z-1655-2010Elekta XiO Radiation Treatment Planning SystemElekta LimitedMUJ
Z-2388-2010GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 (...Siemens Healthcare Diagnostics Inc.CGA
Z-0710-20112.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0709-20112.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0708-20112.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0707-20112.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0706-20112.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0705-20112.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0704-20112.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0703-20112.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0702-20112.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0701-20112.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0700-20112.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0699-20112.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0698-20112.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0697-20112.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0696-20112.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0695-20112.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0694-20112.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0693-20112.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0692-20112.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0691-20112.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0690-20112.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0689-20113.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0688-20113.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0687-20113.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0686-20113.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0685-20113.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY