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 312 of 1190
FDA device recalls, page 312 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0721-2021Class IIADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic...Siemens Healthcare Diagnostics Inc.JQA
Z-0748-2021Class IICovidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3...Medtronic, Inc.GDW
Z-0747-2021Class IICovidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended...Medtronic, Inc.GDW
Z-0719-2021Class IIAPEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product...B Braun Medical IncNEP
Z-0718-2021Class IIAPEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product...B Braun Medical IncNEP
Z-0717-2021Class IIAPEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product...B Braun Medical IncNEP
Z-0715-2021Class IIBaxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended...Baxter Healthcare CorporationFRN
Z-0714-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage...Baxter Healthcare CorporationFRN
Z-0713-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage...Baxter Healthcare CorporationFRN
Z-0712-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage...Baxter Healthcare CorporationFRN
Z-0801-2021Class IIVITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage...Ortho-Clinical Diagnostics, Inc.JJE
Z-0800-2021Class IIenGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product...Ortho-Clinical Diagnostics, Inc.JJE
Z-0696-2021Class IISpinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter...Zimmer GmbHHXZ
Z-0633-2021Class IIHLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number...Maquet Cardiovascular Us Sales, LLCDTZ
Z-0632-2021Class IIHLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part...Maquet Cardiovascular Us Sales, LLCDTZ
Z-0697-2021Class IIHaag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515)...Haag-Streit USA IncHRM
Z-0946-2021Class IMedtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP...HeartWare, Inc.DSQ
Z-0852-2021Class IIEmission Computed Tomography System Image Process System - Product Usage: intended for...Philips North America LLCLLZ
Z-0830-2021Class IIMedisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product...STERIS CorporationFLG
Z-0612-2021Class IIPercept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a...Medtronic NeuromodulationMHY
Z-0846-2021Class IIThe cobas z 480 analyzer including dedicated software for IVD use is a plate-based...Roche Molecular Systems IncMAQ
Z-0756-2021Class IICM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage...Lidco LtdDXG
Z-0587-2021Class IIDePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0586-2021Class IIDePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0585-2021Class IIDePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0584-2021Class IIDePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0583-2021Class IIDePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0582-2021Class IIDePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0581-2021Class IIDePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0580-2021Class IIDePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0579-2021Class IIDePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0578-2021Class IIDePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0577-2021Class IIDePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0576-2021Class IIDePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0575-2021Class IIDePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0574-2021Class IIDePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0573-2021Class IIDePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0572-2021Class IIDePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-0571-2021Class IIDePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical...Synthes (USA) Products LLCHTO
Z-1429-2022Class IIENNOVATE MIS REMOVALKEY SHORT, product code SZ380RAesculap IncLXH
Z-0943-2021Class IIOptilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.AThe Binding Site Group Ltd.DFH
Z-0588-2021Class IIBD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for...Becton Dickinson & CoFMI
Z-0545-2021Class IIPhilips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring...Philips North America LLCDSI
Z-0556-2021Class IIMH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be...Shimadzu Medical SystemsIZI
Z-0544-2021Class IIPhilips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended...Philips North America LLCDSI
Z-0555-2021Class IITrinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support...Shimadzu Medical SystemsOWB
Z-0554-2021Class IIBransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm...Shimadzu Medical SystemsIZI
Z-0693-2021Class IIIceRod" He-Thaw Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0692-2021Class IIIceSeed" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0691-2021Class IIIceRod" i-Thaw" Prostate Cryoablation KitBoston Scientific CorporationGEH