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 191 of 1190
FDA device recalls, page 191 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2372-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight...Medtronic, Inc.NIE
Z-2371-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight...Medtronic, Inc.NIE
Z-2370-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved...Medtronic, Inc.NIE
Z-2369-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved...Medtronic, Inc.NIE
Z-2368-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved...Medtronic, Inc.NIE
Z-2367-2023Class IMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved...Medtronic, Inc.NIE
Z-2274-2023Class IIACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest...Maquet Cardiovascular LLCDWS
Z-2273-2023Class IIACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest...Maquet Cardiovascular LLCDWS
Z-2272-2023Class IIACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest...Maquet Cardiovascular LLCDWS
Z-2271-2023Class IIACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number...Maquet Cardiovascular LLCDWS
Z-2254-2023Class IIZimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm...Zimmer GmbHHRS
Z-2516-2023Class IIFargo Ortho-K LensParagon Vision Sciences, Inc.NUU
Z-2515-2023Class IIISee Ortho-K LensParagon Vision Sciences, Inc.NUU
Z-2214-2023Class IIDigisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting softwareDigisonics, IncLLZ
Z-2364-2023Class IIUroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system...Schoelly Fiberoptic, GmbHHIH
Z-2393-2023Class IIellacor System with Micro-Coring Technology-Indicated for use by medical professionals...Cytrellis Biosystems, Inc.QAI
Z-2251-2023Class IIEquipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent...Microtek Medical LLCKME
Z-2250-2023Class IIEquipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51...Microtek Medical LLCPUI
Z-2224-2023Class IIREINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide...Datascope Corp.DYB
Z-2223-2023Class IILINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter...Datascope Corp.DSP
Z-2222-2023Class IISENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...Datascope Corp.DSP
Z-2221-2023Class IISENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...Datascope Corp.DSP
Z-2220-2023Class IIMEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter...Datascope Corp.DSP
Z-2219-2023Class IIMEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter...Datascope Corp.DSP
Z-2218-2023Class IITRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter...Datascope Corp.DSP
Z-2217-2023Class IISENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...Datascope Corp.DSP
Z-2216-2023Class IIYAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter...Datascope Corp.DSP
Z-2286-2023Class IISTATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health...Scican Ltd.FLE
Z-2285-2023Class IISTATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health...Scican Ltd.FLE
Z-2392-2023Class IIInfx-8000C Xgcp-930Aa Table Side Console, Infx-8000C Xgcp-930Ba Table Side ConsoleCanon Medical Systems USA, Inc.OWB
Z-2253-2023Class IIFusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy...Wilson-Cook Medical Inc.FFL
Z-2252-2023Class IIFusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy...Wilson-Cook Medical Inc.FFL
Z-2249-2023Class IIGore Tips Set Device, Catalog Number TSET1016, percutaneous liver accessCreganna Medical Ireland LimitedDYB
Z-2446-2023Class IIRandox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality...Randox Laboratories, LimitedJJY
Z-2394-2023Class IIHoverMatt, 39" W x 78" L, REF: HM39SPU-BStryker Sustainability SolutionsFRZ
Z-2226-2023Class IIA901 Communication Manager Application, used in conjunction with the A710 Clinician...Medtronic NeuromodulationLGW
Z-2237-2023Class IIRinged DxI Reaction Vessels (RVs)Siemens Healthcare Diagnostics Inc.JJE
Z-2287-2023Class IIProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the...Materialise N.V.JEY
Z-2361-2023Class IIARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and...Siemens Medical Solutions USA, Inc.OWB
Z-2360-2023Class IIARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging...Siemens Medical Solutions USA, Inc.OWB
Z-2359-2023Class IIARTIS icono biplane -Angiography systems developed for single and biplane diagnostic...Siemens Medical Solutions USA, Inc.OWB
Z-2208-2023Class IIGEM FLOW COUPLER Monitor, PN 5156-00000-011Baxter Healthcare CorporationDPW
Z-2405-2023Class IIConformis Hip-Screw-6.5Mm X 25Mm, Sterile EoConforMIS, Inc.OQG
Z-2147-2023Class IINovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010Medtronic, Inc.MPO
Z-2740-2026Class IIBrand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number...3B Medical IncBZD
Z-2445-2023Class IIDOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a...Invacare GmbHITJ
Z-2104-2023Class IThe Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Baxter Healthcare CorporationFRN
Z-2103-2023Class ISIGMA Spectrum Infusion Pump, Product Code 35700BAX2Baxter Healthcare CorporationFRN
Z-2142-2023Class IHAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory...Hamilton Medical AGCBK
Z-2141-2023Class IHAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to...Hamilton Medical AGCBK