510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 651 of 1191
FDA device recalls, page 651 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1646-2015Class IISOMATOM Perspective; the intended use of computed tomography is to produce...Siemens Medical Solutions USA, Inc.JAK
Z-1645-2015Class IISOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional...Siemens Medical Solutions USA, Inc.JAK
Z-1720-2015Class IIRoscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy...Compass Health Brands (Distribution Center)CAF
Z-1644-2015Class IISOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional...Siemens Medical Solutions USA, Inc.JAK
Z-1708-2015Class IIDimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro...Siemens Healthcare Diagnostics Inc.JLW
Z-1595-2015Class II98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP...Abbott MedicalFMG
Z-1594-2015Class II98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve...Abbott MedicalFMG
Z-1593-2015Class II127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve...Abbott MedicalFMG
Z-1592-2015Class II108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve...Abbott MedicalFMG
Z-1591-2015Class II113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve...Abbott MedicalFMG
Z-1590-2015Class II104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext...Abbott MedicalFMG
Z-1589-2015Class II107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer...Abbott MedicalFMG
Z-1588-2015Class II119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3...Abbott MedicalFMG
Z-1701-2015Class IITibial Alignment Guide; Orthopedic Stereotaxic Instrument;Zimmer CASOLO
Z-1642-2015Class IIDeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The...DeRoyal Industries, Inc.GCJ
Z-0275-2016Class IIGMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic SurgeryMedacta USA, Inc.KRO
Z-1542-2015Class IIUltraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2...GE HealthcareDSI
Z-1525-2015Class IIWEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac...Biosense Webster IncDRF
Z-1574-2015Class IIMHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery WorkIYE
Z-1542-2017Class IIHitachi Echelon MRI SystemFUJIFILM Healthcare Americas CorporationLNH
Z-1541-2017Class IIHitachi Echelon Oval MRI SystemFUJIFILM Healthcare Americas CorporationLNH
Z-1540-2017Class IIHitachi Oasis MRI SystemFUJIFILM Healthcare Americas CorporationLNH
Z-2119-2015Class IIHysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO...Medtronic, Inc.FSY
Z-2118-2015Class IINon Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE...Medtronic, Inc.FSY
Z-2117-2015Class IINS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711Medtronic, Inc.FSY
Z-2116-2015Class IIAugmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2115-2015Class IISingle Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2114-2015Class IIMajor Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description...Medtronic, Inc.FSY
Z-2113-2015Class IIDouble Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2112-2015Class IISurgical Kit Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2111-2015Class IIASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2110-2015Class IISurgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2109-2015Class IIMinor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2108-2015Class IIMini-Kits, Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-2107-2015Class IIDelivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog...Medtronic, Inc.FSY
Z-1757-2015Class IIIBiomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR...Zimmer GmbHJDI
Z-1756-2015Class IIIMCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM...Zimmer GmbHJWH
Z-1755-2015Class IIIComprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V...Zimmer GmbHMBF
Z-1754-2015Class IIIMallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V...Zimmer GmbHLPH
Z-1627-2015Class IIPhalinx (Tm) Hammertoe Handle, Size: Large, Style: Angled, Ref 45304014, Contents 1 Each...Wright Medical Technology IncHWC
Z-1626-2015Class IIPhalinx (Tm) Hammertoe Handle, Size: Medium, Style: Angled, Ref 45304013, Contents 1...Wright Medical Technology IncHWC
Z-1625-2015Class IIPhalinx (Tm) Hammertoe Handle, Size: Small, Style: Angled, Ref 45304012, Contents 1 Each...Wright Medical Technology IncHWC
Z-1624-2015Class IIPhalinx (Tm) Hammertoe Handle, Size: X-Small, Style: Angled, Ref 45304011, Contents 1...Wright Medical Technology IncHWC
Z-1605-2015Class IITapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage...BioHorizons Implant Systems IncDZE
Z-2106-2015Class IICovidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use...Medtronic, Inc.FSY
Z-1617-2015Class IIMedtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. SterileMedtronic NeuromodulationMHY
Z-2323-2015Class IReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR...Alcon LaboratoriesHQL
Z-0408-2016Class IIPhilips Healthcare Ingenuity CT Computed Tomography X-ray systemPhilips North America LLCJAK
Z-0407-2016Class IIPhilips Healthcare Ingenuity Core 128 Computed Tomography X-ray systemPhilips North America LLCJAK
Z-0406-2016Class IIPhilips Healthcare Ingenuity Core Computed Tomography X-ray systemPhilips North America LLCJAK