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 64 of 1190
FDA device recalls, page 64 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0178-2026Class IIMedical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD...American Contract Systems, Inc.OGR
Z-0177-2026Class IIMedical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION...American Contract Systems, Inc.OFF
Z-0176-2026Class IIMedical convenience kits Item Number/Description ANCV78BC HEART PACK...American Contract Systems, Inc.OEZ
Z-0175-2026Class IIMedical convenience kits Item Number/Description EVLH67F LEFT HEART CATH...American Contract Systems, Inc.OES
Z-0174-2026Class IIMedical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK...American Contract Systems, Inc.NWU
Z-0173-2026Class IIMedical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK...American Contract Systems, Inc.MLS
Z-0172-2026Class IIMedical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST...American Contract Systems, Inc.LRO
Z-0171-2026Class IIBasic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL...American Contract Systems, Inc.FDE
Z-0170-2026Class IIBasic Biopsy Tray, Item Number NMBP44LAmerican Contract Systems, Inc.FCH
Z-0146-2026Class IIXERF EFFECTOR 60. Electrosurgical unit.Lutronic CorporationGEI
Z-0131-2026Class IINeuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated...Contego Medical, IncNIM
Z-0071-2026Class IISYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx...Siemens Healthcare Diagnostics Inc.CEO
Z-0107-2026Class IIFlexLab X (FXX) System. Potassium Test System. in vitro diagnosticInpeco S.p.A.CEM
Z-0106-2026Class IIFlexLab (FLX) System. Potassium Test System. in vitro diagnosticInpeco S.p.A.CEM
Z-0378-2026Class IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Fresenius Kabi USA, LLCFRN
Z-0015-2026Class IICardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005...Philips Medical Systems Nederland B.V.OWB
Z-0014-2026Class IIAllura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842...Philips Medical Systems Nederland B.V.OWB
Z-0013-2026Class IIAllura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005...Philips Medical Systems Nederland B.V.OWB
Z-0012-2026Class IIAllura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638...Philips Medical Systems Nederland B.V.OWB
Z-0011-2026Class IIAllura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005...Philips Medical Systems Nederland B.V.OWB
Z-0010-2026Class IIAllura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638...Philips Medical Systems Nederland B.V.OWB
Z-0009-2026Class IIAllura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638...Philips Medical Systems Nederland B.V.OWB
Z-0008-2026Class IIAllura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated...Philips Medical Systems Nederland B.V.OWB
Z-0007-2026Class IIAllura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated...Philips Medical Systems Nederland B.V.OWB
Z-0006-2026Class IIAllura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s...Philips Medical Systems Nederland B.V.OWB
Z-0005-2026Class IIAllura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s...Philips Medical Systems Nederland B.V.OWB
Z-0004-2026Class IIAllura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638...Philips Medical Systems Nederland B.V.OWB
Z-0003-2026Class IIAllura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated...Philips Medical Systems Nederland B.V.OWB
Z-0002-2026Class IIAllura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s...Philips Medical Systems Nederland B.V.OWB
Z-0001-2026Class IIAllura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842...Philips Medical Systems Nederland B.V.OWB
Z-2635-2025Class IIAllura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638...Philips Medical Systems Nederland B.V.OWB
Z-2634-2025Class IIAllura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005...Philips Medical Systems Nederland B.V.OWB
Z-2633-2025Class IIAllura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842...Philips Medical Systems Nederland B.V.OWB
Z-2632-2025Class IIAllura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842...Philips Medical Systems Nederland B.V.OWB
Z-2631-2025Class IIAllura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005...Philips Medical Systems Nederland B.V.OWB
Z-2630-2025Class IIAllura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842...Philips Medical Systems Nederland B.V.OWB
Z-2629-2025Class IIAllura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k)...Philips Medical Systems Nederland B.V.OWB
Z-2628-2025Class IIAllura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated...Philips Medical Systems Nederland B.V.OWB
Z-2627-2025Class IIAllura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers...Philips Medical Systems Nederland B.V.OWB
Z-2626-2025Class IIAllura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k)...Philips Medical Systems Nederland B.V.OWB
Z-2625-2025Class IIAllura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k)...Philips Medical Systems Nederland B.V.OWB
Z-2624-2025Class IIAllura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k)...Philips Medical Systems Nederland B.V.OWB
Z-2623-2025Class IIAllura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k)...Philips Medical Systems Nederland B.V.OWB
Z-0540-2026Class IITribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17)...Berkeley Advanced BiomaterialsMQV
Z-0037-2026Class IIThis device is a digital radiography/fluoroscopy system used in a diagnostic and...Canon Medical Systems USA, Inc.OWB
Z-0034-2026Class IIArtegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4)...LeMaitre Vascular Inc.LXA
Z-2571-2025Class IIThe product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter...BigTree Sales Inc.RHP
Z-0204-2026Class IICLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519Baxter Healthcare CorporationFMG
Z-0203-2026Class IICLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK...Baxter Healthcare CorporationFMG
Z-0202-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated...Baxter Healthcare CorporationFMG