510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 45 of 1190
FDA device recalls, page 45 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1045-2026Class IISMV DSI, System, Tomography, Computed, EmissionGE Medical Systems Israel, Functional ImagingKPS
Z-1044-2026Class IISMV DSX New Line, System, Tomography, Computed, EmissionGE Medical Systems Israel, Functional ImagingIYX
Z-1078-2026Class IIMOSAIQ Oncology Information System with Particle Therapy License (License Kit...Elekta LimitedIYE
Z-1701-2026Class IIBrand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si...Intuitive Surgical, Inc.NAY
Z-1700-2026Class IIBrand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si...Intuitive Surgical, Inc.NAY
Z-1699-2026Class IIBrand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si...Intuitive Surgical, Inc.NAY
Z-1698-2026Class IIBrand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si...Intuitive Surgical, Inc.NAY
Z-1697-2026Class IIBrand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci...Intuitive Surgical, Inc.NAY
Z-1696-2026Class IIBrand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S...Intuitive Surgical, Inc.NAY
Z-1083-2026Class IIBrand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog...Heraeus Medical GmbHLOD
Z-1082-2026Class IIBrand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog...Heraeus Medical GmbHLOD
Z-1081-2026Class IIBrand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog...Heraeus Medical GmbHLOD
Z-1080-2026Class IIBrand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog...Heraeus Medical GmbHLOD
Z-1034-2026Class IIBrand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number...IMRIS Imaging, Inc.HBL
Z-1032-2026Class IIArial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3Securitas Healthcare LLCIQA
Z-1031-2026Class IIArial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3Securitas Healthcare LLCIQA
Z-1135-2026Class IIThe LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique...Beckman Coulter Ireland IncLBS
Z-1079-2026Class IIPhilips Azurion Systems R3.0. Includes the following label descriptions and corresponding...Philips Medical Systems Nederland B.V.OWB
Z-0999-2026Class IILUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471Siemens Medical Solutions USA, Inc.OWB
Z-1218-2026Class IIBrand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23LimFlow Inc.MGZ
Z-1008-2026Class IIBVI Leos Laser and Endoscopy System. Model Number: OME6000U.Becton Dickinson & CoHQF
Z-1019-2026Class IIRevogene C. difficile, in vitro diagnostic assay intended for use with the Revogene...Meridian Bioscience IncOZN
Z-1134-2026Class IIBrand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog...Intuitive Surgical, Inc.EOQ
Z-1129-2026Class IIAllwell Angioplasty Pack REF: IS-30-B1/BMerit Medical Systems, Inc.OEQ
Z-1128-2026Class IIMerit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956...Merit Medical Systems, Inc.OEQ
Z-1127-2026Class IIMerit Medical , Custom Manifold Kit REF: K09-13203AMerit Medical Systems, Inc.OEZ
Z-1126-2026Class IIMerit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05...Merit Medical Systems, Inc.PPD
Z-1125-2026Class IIMerit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261Merit Medical Systems, Inc.PPD
Z-1098-2026Class IIAbre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080...Medtronic, Inc.QAN
Z-1124-2026Class IIAllwell Inflation Device, for angiographic use REF: IS-30-AMerit Medical Systems, Inc.OEQ
Z-1123-2026Class IIMerit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers...Merit Medical Systems, Inc.PTM
Z-1041-2026Class IIDetachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray...Brainlab, Inc.JAK
Z-1040-2026Class IIDetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray...Brainlab, Inc.JAK
Z-1030-2026Class IIImpella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.Abiomed, Inc.OZD
Z-1003-2026Class IIPhilips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.JAK
Z-1042-2026Class IIBoston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm...Boston Scientific CorporationLIT
Z-1216-2026Class IISmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW...Philips North America LLCLNH
Z-1215-2026Class IISmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version...Philips North America LLCLNH
Z-1214-2026Class IIUpgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and...Philips North America LLCLNH
Z-1213-2026Class IIMR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1...Philips North America LLCLNH
Z-1212-2026Class IIIngenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems...Philips North America LLCLNH
Z-1211-2026Class IIIngenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems...Philips North America LLCLNH
Z-1210-2026Class IIIngenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems...Philips North America LLCLNH
Z-1209-2026Class IIIngenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and...Philips North America LLCLNH
Z-1208-2026Class IIIngenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.Philips North America LLCLNH
Z-1207-2026Class IIIngenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version...Philips North America LLCLNH
Z-1206-2026Class IIIngenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version...Philips North America LLCLNH
Z-1205-2026Class IIEvolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1...Philips North America LLCLNH
Z-1204-2026Class IIEvolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW...Philips North America LLCLNH
Z-1043-2026Class IIA71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683...Medtronic NeuromodulationLGW