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 616 of 1191
FDA device recalls, page 616 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0551-2016Class IITerumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product...Terumo Medical Corp.MEG
Z-0417-2016Class IICournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The...Stryker Corp.DYB
Z-0653-2016Class II30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General...Intuitive Surgical, Inc.NAY
Z-0652-2016Class II0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General...Intuitive Surgical, Inc.NAY
Z-0556-2016Class IIGranada Biphasic Broth The product is a selective medium for the screening and...bioMerieux, Inc.NJR
Z-0479-2016Class IIVAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)DePuy Mitek, Inc.GEI
Z-0698-2016Class IIWARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch...Bigwall EnterprisesKFZ
Z-0603-2016Class IIAMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of...STERIS CorporationLGZ
Z-0450-2016Class IIA.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation...Zimmer GmbHHRS
Z-0465-2016Class IIIntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40...Boston Scientific CorporationOAD
Z-0464-2016Class IIIntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40...Boston Scientific CorporationOAD
Z-0463-2016Class IIIntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number...Boston Scientific CorporationOAD
Z-0462-2016Class IIIntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number...Boston Scientific CorporationOAD
Z-0658-2016Class IIFMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to...DePuy Mitek, Inc.HRX
Z-0657-2016Class IIFMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to...DePuy Mitek, Inc.HRX
Z-0656-2016Class IIFMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to...DePuy Mitek, Inc.HRX
Z-0415-2016Class IICatalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector...Zevex, Inc.PIF
Z-0543-2016Class IICardinal Health Tiny Toes; 11470-010T Infant heel warmerPhilips North America LLCIMD
Z-0454-2016Class IIAegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the...DePuy Spine, Inc.KWQ
Z-0587-2016Class IMOVES System Lithium Polymer Batteries The MOVES System is a portable computer...Thornhill Research IncBTL
Z-0586-2016Class IMOVES System, an emergency ventilator with suction, oxygen concentrator and...Thornhill Research IncBTL
Z-0442-2016Class IEtest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique...bioMerieux, Inc.JWY
Z-0441-2016Class IEtest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique...bioMerieux, Inc.JWY
Z-0440-2016Class IEtest PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest is a quantitative technique for...bioMerieux, Inc.JWY
Z-0439-2016Class IEtest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a...bioMerieux, Inc.JWY
Z-0468-2016Class IIFactor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN)...Siemens Healthcare Diagnostics Inc.GGP
Z-0416-2016Class IIVentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of...Cook IncorporatedNHC
Z-0392-2016Class IBoston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene...Boston Scientific CorporationDYB
Z-1595-2016Class IITCM CombiM Modules 903-111Radiometer America, IncLKD
Z-0470-2016Class IIFB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious...Hardy DiagnosticsJSC
Z-0597-2016Class IISoftware version VD10E for Syngo X-Workplace; Picture archiving and communication system.Siemens Medical Solutions USA, Inc.LLZ
Z-0477-2016Class IIDressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients...Rainbow Specialty & Health ProductsGDY
Z-0476-2016Class IIDressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients...Rainbow Specialty & Health ProductsGDY
Z-0397-2016Class IIIBS - Osteosynthesis screws for bone fixation Model S25 ST014.In2Bones SASHWC
Z-0645-2016Class IICyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106LivaNova USA, Inc.LYJ
Z-0767-2016Class IIMEVION S250 Radiation therapy systemMevion Medical Systems, Inc.LHN
Z-1180-2017Class IIMerge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.Merge Healthcare IncorporatedLLZ
Z-1669-2016Class IILumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter...Lumenis LtdGEX
Z-1173-2016Class IIIZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental...Collagen Matrix, IncNPM
Z-0735-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36)...Owens & Minor Distribution, Inc.KGX
Z-0734-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36)...Owens & Minor Distribution, Inc.KGX
Z-0733-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36)...Owens & Minor Distribution, Inc.KGX
Z-0550-2016Class IISyngo Imaging XS is a Picture Archiving and Communication System (PACS)Siemens Medical Solutions USA, Inc.LLZ
Z-0625-2016Class IIZimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system...Zimmer GmbHKWP
Z-0403-2016Class IIOlympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree...OLYMPUS Corporation of the AmericasHET
Z-0478-2016Class IThe Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial...Stryker Sustainability SolutionsKDQ
Z-0566-2016Class IIValve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in...Aesculap IncGAD
Z-0456-2016Class IIBD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD...Becton Dickinson & CoJKA
Z-0650-2016Class IIBiomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm...Zimmer GmbHLZO
Z-1613-2016Class IINovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad CorporationNovarad Corp.LLZ