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

59,336 records, page 34 of 1187
FDA device recalls, page 34 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2268-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH...B Braun Medical IncOGE
Z-2267-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL...B Braun Medical IncOFT
Z-2266-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog...B Braun Medical IncOGE
Z-2265-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP...B Braun Medical IncOFT
Z-2264-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog...B Braun Medical IncCAZ
Z-2263-2026Class IIBrand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA...B Braun Medical IncOGE
Z-1655-2026Class IIBrand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise...Recor MedicalQYI
Z-1654-2026Class IIBrand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise...Recor MedicalQYI
Z-1489-2026Class IIOlympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The...OLYMPUS Corporation of the AmericasEOQ
Z-1488-2026Class IIOlympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The...OLYMPUS Corporation of the AmericasEOQ
Z-1564-2026Class IIMedline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT...MEDLINE INDUSTRIES, LP - NorthfieldPUI
Z-1563-2026Class IIMedline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN...MEDLINE INDUSTRIES, LP - NorthfieldFYA
Z-1689-2026Class IIJiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.Ultradent Products Inc.EHJ
Z-1558-2026Class IICLARITY II Laser System; Model No. 1110200210.Lutronic CorporationGEX
Z-1496-2026Class II10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk...Becton Dickinson & CoFMF
Z-1471-2026Class IImpella RP. Product Code: 0046-0011.Abiomed, Inc.PYX
Z-1470-2026Class IImpella RP Flex with SmartAssist. Product Code: 1000323.Abiomed, Inc.PYX
Z-1469-2026Class IImpella RP with SmartAssist. Product Code: 0046-0035.Abiomed, Inc.PYX
Z-1351-2026Class IIAzurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software...Philips Medical Systems Nederland B.V.OWB
Z-1350-2026Class IIAzurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All...Philips Medical Systems Nederland B.V.OWB
Z-1349-2026Class IIAzurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS...Philips Medical Systems Nederland B.V.OWB
Z-1348-2026Class IIAzurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version...Philips Medical Systems Nederland B.V.OWB
Z-1347-2026Class IIAzurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version...Philips Medical Systems Nederland B.V.OWB
Z-1346-2026Class IIAzurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version...Philips Medical Systems Nederland B.V.OWB
Z-1345-2026Class IIAzurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS...Philips Medical Systems Nederland B.V.OWB
Z-1344-2026Class IIAzurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version...Philips Medical Systems Nederland B.V.OWB
Z-1487-2026Class IICS300 IABP. Software Version CS300 IABP C.01.Datascope Corp.DSP
Z-1608-2026Class IIBrand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below...I.T.S. GmbHHRS
Z-1607-2026Class IIHLS - Hand Locking Plates System with the below descriptions and corresponding article...I.T.S. GmbHHRS
Z-1606-2026Class IIHCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article...I.T.S. GmbHHWC
Z-1605-2026Class IIFLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below...I.T.S. GmbHHRS
Z-1604-2026Class III.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the...I.T.S. GmbHHRS
Z-1603-2026Class III.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding...I.T.S. GmbHHRS
Z-1602-2026Class IIDistal Humeral Plates with Angular Stability with the below descriptions and...I.T.S. GmbHHRS
Z-1601-2026Class III.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and...I.T.S. GmbHHRS
Z-1600-2026Class IIPelvic Reconstruction System (PRS) with the below descriptions and corresponding article...I.T.S. GmbHHRS
Z-1599-2026Class III.T.S. Screw System with the below descriptions and corresponding article numbers. 1...I.T.S. GmbHHWC
Z-1598-2026Class III.T.S. Straight Plate with Angular Stability with the below descriptions and...I.T.S. GmbHHRS
Z-1597-2026Class IIOlecranonplate with Angular Stability with the below descriptions and corresponding...I.T.S. GmbHHRS
Z-1596-2026Class IIPilonplate with Angular Stability, with the below descriptions and corresponding article...I.T.S. GmbHHRS
Z-1595-2026Class IIFR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus...I.T.S. GmbHHRS
Z-1594-2026Class IIBrand Name: Humeral Head Plate with Angular Stability, with the following description...I.T.S. GmbHHRS
Z-1593-2026Class IIClaviculaplate with Angular Stability, with the below descriptions and associated article...I.T.S. GmbHHRS
Z-1592-2026Class IIVolar Radius Plate with Angular Stability with the following description: Radius Plate...I.T.S. GmbHHRS
Z-1486-2026Class IICS100 IABP. Software Version CS100 IABP Q.01.Datascope Corp.DSP
Z-1480-2026Class IIEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Staar Surgical AGQCB
Z-1472-2026Class IIAdapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support...Agiliti Health - EllisFNM
Z-1427-2026Class IIMOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and...Stryker Corp.NEU
Z-1383-2026Class IIMONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R...Auris Health, IncEOQ
Z-1544-2026Class IIPHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers...Physio Control, Inc.MKJ