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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 360 of 1190
FDA device recalls, page 360 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1145-2020Class IIVesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2...Philips North America LLCOWB
Z-0988-2020Class IIJamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00Zimmer GmbHKNW
Z-0877-2020Class IISIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt...GE HealthcareLNH
Z-0876-2020Class IISIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body...GE HealthcareLNH
Z-0875-2020Class IISIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole...GE HealthcareLNH
Z-0874-2020Class IISIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body...GE HealthcareLNH
Z-1550-2020Class IIMVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24Mavidon Medical ProdKOY
Z-1549-2020Class IIPediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)Mavidon Medical ProdKOY
Z-1548-2020Class IILemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)Mavidon Medical ProdKOY
Z-1363-2020Class IIADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI...Siemens Healthcare Diagnostics Inc.CHI
Z-1255-2020Class IIArrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSBArrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-1254-2020Class IIPICC Set- PR-35052-HPHNMArrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-1253-2020Class II(1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1252-2020Class IIArrow EPIDURAL NEEDLE KIT SL-05500Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1251-2020Class IIArrow EPIDURAL CATHETERIZATION COMPONENT EC-05000Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1250-2020Class IIArrow SPINAL ANESTHESIA SET ASA-25090-SArrow International LLC (subsidiary of Teleflex Incorporated)BSP
Z-1249-2020Class IIArrow EPIDURAL CATHETERIZATION KIT CK-02220Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1248-2020Class IIArrow EPIDURAL CATHETERIZATION KIT AM-05500Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1247-2020Class IIArrow EPIDURAL CATHETERIZATION KIT JH-05500Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1246-2020Class IIArrow EPIDURAL CATHETERIZATION KIT YC-02220Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1245-2020Class IIArrow EPIDURAL CATHETERIZATION KIT AK-05000Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1244-2020Class IIArrow EPIDURAL NEEDLE COMPONENT AN-05505Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1243-2020Class IIArrow Central Venous Catheterization Kit ASK-04200-UPMArrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1242-2020Class IIArrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPMArrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-1241-2020Class IIArrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-0863-2020Class IICustom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis...Manus Medical, LLCLRO
Z-1240-2020Class IIArrow Maximal Barrier Drape ASK-00002-1AArrow International LLC (subsidiary of Teleflex Incorporated)KKX
Z-1239-2020Class IIArrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WHArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1238-2020Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CANArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1237-2020Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSCArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1236-2020Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-0817-2020Class IILIFEPAK 15 MONITOR/DEFIBRILLATOR service kitsPhysio Control, Inc.MKJ
Z-0807-2020Class IISiemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System...Siemens Medical Solutions USA, Inc.OWB
Z-0816-2020Class IILIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade...Physio Control, Inc.MKJ
Z-2329-2020Class IISTAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03...Intuitive Surgical, Inc.KCT
Z-2328-2020Class IISTAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product...Intuitive Surgical, Inc.KCT
Z-1329-2020Class IICombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system...Philips Medical Systems DMC GmbHJAA
Z-1328-2020Class IICombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system...Philips Medical Systems DMC GmbHJAA
Z-0866-2020Class IIRayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7...RaySearch Laboratories AB (publ)MUJ
Z-1507-2020Class IILEGION PS High Flex XLPE size 5-6 9mm Articular InsertSmith & Nephew, Inc.JWH
Z-1349-2020Class IIRX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without...Randox Laboratories, LimitedJJE
Z-0871-2020Class IIASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product...Zimmer GmbHLXH
Z-2473-2020Class IIElekta Unity, Image-Guided Radiation Therapy SystemElekta LimitedIYE
Z-1300-2020Class IIBiosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201Medtronic, Inc.GAM
Z-1299-2020Class IIPolysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage...Medtronic, Inc.GAM
Z-1298-2020Class IIPolysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage...Medtronic, Inc.GAM
Z-1297-2020Class IIPolysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage...Medtronic, Inc.GAM
Z-1296-2020Class IIPolysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage...Medtronic, Inc.GAM
Z-1295-2020Class IIPolysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage...Medtronic, Inc.GAM
Z-1294-2020Class IIPolysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage...Medtronic, Inc.GAM