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 814 of 1190
FDA device recalls, page 814 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0930-2012The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed...Depuy Orthopaedics Inc.HWA
Z-0205-2013Class IIVector TAS Modular Driver, a manual driver for Vector TAS dental screws.Ormco/SybronendoDZN
Z-1070-2012Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication...Canadian Hospital Specialties Ltd.KYX
Z-0736-2012Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model...Varian Medical Systems, Inc.MUJ
Z-0872-2012Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health...Medtronic, Inc.LRP
Z-0691-20124D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical...Varian Medical Systems, Inc.IYE
Z-0716-2012Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA...Varian Medical Systems, Inc.IYE
Z-0715-2012Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier...Varian Medical Systems, Inc.IYE
Z-0871-2012Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal...Medtronic, Inc.LRO
Z-0860-2012Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic...Siemens Medical Solutions USA, Inc.MQB
Z-0806-2012Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a...OLYMPUS Corporation of the AmericasFEQ
Z-0276-2013Class IIProgressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder...Progressive Medical IncGDI
Z-0775-2012CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in...Abbott MedicalFPA
Z-2088-2012Class IIPrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671)...Becton Dickinson & CoMKQ
Z-2087-2012Class IIPrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell...Becton Dickinson & CoMKQ
Z-2086-2012Class IIPrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based...Becton Dickinson & CoMKQ
Z-2085-2012Class IIPrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell...Becton Dickinson & CoMKQ
Z-1046-2012Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial...Philips North America LLCJAK
Z-0738-2012Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed...Linet AmericasFNL
Z-1267-2012Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903Customed, IncMCY
Z-1266-2012Wound Management Ryder, catalog# 900-1605Customed, IncMCY
Z-1265-2012Wound Management Tray, catalog# 900-1456Customed, IncMCY
Z-1264-2012Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154Customed, IncMCY
Z-1263-2012Wound Management Tray, catalog# 900-540Customed, IncMCY
Z-1262-2012Wound Closure Tray II, catalog# 900-064Customed, IncLRO
Z-1261-2012Wound Closure Tray I, catalog# 900-063Customed, IncLRO
Z-1260-2012Minor laceration tray , catalog# 900-1765Customed, IncLRO
Z-1259-2012Skin Stapler Removal Kit , catalog# 900-782Customed, IncMCZ
Z-1258-2012Incision and Drainage Tray, catalog# 900-774Customed, IncFSM
Z-1257-2012Urethral Catheter Tray catalog# 900-278Customed, IncFCM
Z-1256-2012Suction Catheter Kit, catalog# 900-277Customed, IncLRO
Z-1255-2012Tracheotomy care kit, catalog# 900-110Customed, IncJOH
Z-1254-2012Universal drainage kit, catalog# 900-032Customed, IncFCM
Z-1253-2012Prep shave kit, catalog# 900-030Customed, IncLRO
Z-1252-2012Irrigation Tray w/Bulb syringe, catalog# 900-020Customed, IncKYZ
Z-1251-2012Suture removal kit, catalog# 900-010Customed, IncMCZ
Z-0607-2012SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the...Philips North America LLCKPS
Z-0869-2012STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k)...STERIS CorporationMED
Z-0774-2012Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor...Invacare GmbHINI
Z-0605-2012ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707...Salter LabsCCK
Z-0604-2012CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen...Terumo Cardiovascular Systems CorporationDRY
Z-1317-2012RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch...RaySearch Laboratories AB (publ)MUJ
Z-0591-2012Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same...AGFA Healthcare Corp.MQB
Z-0678-2012Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales...Teleflex MedicalGDG
Z-0677-2012Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages...Teleflex MedicalGDG
Z-1475-2012UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is...Securitas Healthcare LLCKMI
Z-0482-2012Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen...Baxter Healthcare CorporationFPA
Z-0481-2012Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen...Baxter Healthcare CorporationFPA
Z-0480-2012Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male...Baxter Healthcare CorporationFMG
Z-0479-2012Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock...Baxter Healthcare CorporationFMG