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

59,486 records, page 861 of 1190
FDA device recalls, page 861 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0552-2012Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, each kit packed in a...Heritage Labs International LLCLCP
Z-0551-2012Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag...Heritage Labs International LLCLCP
Z-0550-2012Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, each kit packed in...Heritage Labs International LLCLCP
Z-0549-2012Medical Mutual Blood Collection Kit, Product K6500, each kit packed in a bag or envelope...Heritage Labs International LLCKDT
Z-0548-2012Nationwide DBS Collection Kit, Product K4003, each kit packed in a bag or envelope and...Heritage Labs International LLCLCP
Z-0547-2012Appraise DBS Kit, Product K4002, each kit packed in a bag or envelope and contains 1...Heritage Labs International LLCLCP
Z-0546-2012Heritage Labs Yale Research Kit, Product A2364, 50 kits/shipping carton, each kit packed...Heritage Labs International LLCKDT
Z-0545-2012The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product...Heritage Labs International LLCKDT
Z-0544-2012The National Children's Study Adult Blood Birth Mother Kit/Heritage Labs Westat Birth...Heritage Labs International LLCKDT
Z-0543-2012AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each kit...Heritage Labs International LLCKDT
Z-0542-2012AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit...Heritage Labs International LLCJKA
Z-0541-2012The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail...Heritage Labs International LLCKDT
Z-0540-2012The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair...Heritage Labs International LLCKDT
Z-0539-2012The National Children's Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father...Heritage Labs International LLCKDT
Z-0538-2012The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother...Heritage Labs International LLCKDT
Z-0537-2012The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother...Heritage Labs International LLCKDT
Z-0536-2012The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523...Heritage Labs International LLCKDT
Z-0535-2012Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit...Heritage Labs International LLCJKA
Z-0534-2012Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12...Heritage Labs International LLCKDT
Z-0533-2012H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25...Heritage Labs International LLCKDT
Z-0532-2012Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope...Heritage Labs International LLCLCP
Z-0531-2012Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in...Heritage Labs International LLCLCP
Z-0530-2012Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in...Heritage Labs International LLCLCP
Z-0529-2012Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or...Heritage Labs International LLCLCP
Z-0528-2012Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or...Heritage Labs International LLCLCP
Z-0527-2012Benicomp Supplies Kit, Product A1740. Each kit contains 1 Triad Medium Alcohol Prep Pad...Heritage Labs International LLCLCP
Z-0526-2012Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1...Heritage Labs International LLCLCP
Z-0525-2012Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25...Heritage Labs International LLCLCP
Z-2896-2011Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical...Canon Medical Systems USA, Inc.JAK
Z-2895-2011Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical...Canon Medical Systems USA, Inc.JAK
Z-1219-2011Pulmonary Valve & Conduit SG Used in heart surgeryArtivion, Inc.MIE
Z-1742-2011UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah...Ortho Development Corp.JWH
Z-1741-2011CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah...Ortho Development Corp.JWH
Z-1740-2011UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah...Ortho Development Corp.JWH
Z-1067-2011Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images...FUJIFILM Healthcare Americas Corporation
Z-1247-2011Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677...Howmedica Osteonics CorpLXH
Z-1256-2011Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with...ConvaTec LimitedBYG
Z-1255-2011Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for...ConvaTec LimitedBYL
Z-1382-2011XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #...Davol Inc., Sub. C.R. Bard, Inc.FTM
Z-1381-2011XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #...Davol Inc., Sub. C.R. Bard, Inc.FTM
Z-1380-2011XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #...Davol Inc., Sub. C.R. Bard, Inc.FTM
Z-1379-2011XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #...Davol Inc., Sub. C.R. Bard, Inc.FTM
Z-2793-2011Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and...Abbott VascularDQY
Z-2792-2011Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For...Abbott VascularDTL
Z-2791-2011Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac...Abbott VascularDQX
Z-1885-2011MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for...Microtek Medical LLCCAE
Z-1252-2011Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic...Elekta LimitedIYE
Z-2168-2011Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3...Respironics Novametrix, LLC.
Z-2167-2011Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3...Respironics Novametrix, LLC.
Z-2133-2012Class III-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is...Abbott MedicalCHL