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 80 of 1190
FDA device recalls, page 80 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2002-2025Class IIREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2001-2025Class IIREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2000-2025Class IIREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-1999-2025Class IIREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM)...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-1915-2025Class INewport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR...Medtronic, Inc.CBK
Z-1998-2025Class IILUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external...Jolife ABDRM
Z-2077-2025Class IIColoSense Test Kit, Part No. 80-001, component of ColoSense testGeneoscopy, Inc.SBB
Z-2042-2025Class IIMy3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a...Onkos Surgical, Inc.QHQ
Z-2023-2025Class IIBD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of...Becton Dickinson & CoMJA
Z-2100-2025Class IIBrand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird...Neurovision Medical Products IncETN
Z-2025-2025Class IIPRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileLimacorporate S.p.A.PHX
Z-2024-2025Class IIPRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileLimacorporate S.p.A.PHX
Z-1822-2026Class IIBrand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis...Therakos Development LimitedLNR
Z-2330-2025Class IIBrand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number...Drs Vascular, IncKGS
Z-2030-2025Class IIGE Healthcare Versana Ultrasound Systems, sold under the following names and...GE Medical Systems China Co., Ltd.IYN
Z-2029-2025Class IIGE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic...GE Medical Systems China Co., Ltd.IYN
Z-2022-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB
Z-2021-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB
Z-2020-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB
Z-2019-2025Class IIARTIS is a family of dedicated angiography systems developed for single and biplane...Siemens Medical Solutions USA, Inc.OWB
Z-1995-2025Class IIMedline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1956-2025Class IIContamac, Nutrifill Physiologic formula, Contact Lens Insertion solutionContamac Solutions, Inc.MRC
Z-1904-2025Class IBroselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA...Salter LabsOKI
Z-1902-2025Class IBeacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and...Cook IncorporatedDQO
Z-2085-2025Class IBrand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number...Edwards Lifesciences LLCDQR
Z-2084-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number...Edwards Lifesciences LLCDQR
Z-2083-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number...Edwards Lifesciences LLCDQR
Z-2082-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number...Edwards Lifesciences LLCDQR
Z-2081-2025Class IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial...Edwards Lifesciences LLCDQR
Z-2080-2025Class IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial...Edwards Lifesciences LLCDQR
Z-1942-2025Class IIAmi HTX.Spectral Instruments IncRCE
Z-1941-2025Class IILago XSpectral Instruments IncRCE
Z-1805-2025Class IIProduct Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;Philips North America LLCLNH
Z-1804-2025Class IIProduct Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;Philips North America LLCLNH
Z-1803-2025Class IIProduct Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;Philips North America LLCLNH
Z-1802-2025Class IIProduct Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;Philips North America LLCLNH
Z-1801-2025Class IIProduct Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;Philips North America LLCLNH
Z-1800-2025Class IIProduct Name: Ingenia 3.0T CX; Model Number: 781271;Philips North America LLCLNH
Z-1799-2025Class IIProduct Name: Ingenia 1.5T CX; Model Number: 781262;Philips North America LLCLNH
Z-1798-2025Class IIProduct Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;Philips North America LLCLNH
Z-1797-2025Class IIProduct Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;Philips North America LLCLNH
Z-1796-2025Class IIProduct Name: Ingenia 1.5T S; Model Number: 781347;Philips North America LLCLNH
Z-1795-2025Class IIProduct Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4)...Philips North America LLCLNH
Z-1794-2025Class IIProduct Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;Philips North America LLCLNH
Z-1793-2025Class IIProduct Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;Philips North America LLCLNH
Z-1792-2025Class IIProduct Name: Upgrade to MR 7700; Model Number: 782130;Philips North America LLCLNH
Z-1791-2025Class IIProduct Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;Philips North America LLCLNH
Z-1790-2025Class IIProduct Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;Philips North America LLCLNH
Z-1789-2025Class IIProduct Name: SmartPath to dStream for 3.0T; Model Number: 782145Philips North America LLCLNH
Z-1788-2025Class IIProduct Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3)...Philips North America LLCLNH