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 94 of 1190
FDA device recalls, page 94 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1348-2025Class IIDELIVERY PACK , Model No SGDV22D-01 SGDV22EAmerican Contract Systems, Inc.MLS
Z-1347-2025Class IITOTAL HIP PACK , Model No SMTH06O SMTH06PAmerican Contract Systems, Inc.OJH
Z-1346-2025Class IICYSTO , Model No SACY80RAmerican Contract Systems, Inc.NWU
Z-1345-2025Class IIURO ROBOTIC PACK , Model No LVUR44C LVUR44C-03American Contract Systems, Inc.LRO
Z-1344-2025Class IILABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02American Contract Systems, Inc.MLS
Z-1343-2025Class IICENTRAL LINE PICC , Model No LLCL44H LLCL44H-01American Contract Systems, Inc.OKE
Z-1342-2025Class IIC-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04American Contract Systems, Inc.OHM
Z-1341-2025Class IIBORN ON ARRIVAL KIT , Model No LLBN11BAmerican Contract Systems, Inc.MLS
Z-1340-2025Class IIGENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03American Contract Systems, Inc.OEQ
Z-1339-2025Class IIOPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IAmerican Contract Systems, Inc.OEZ
Z-1338-2025Class IILABOR & DELIVERY PACK, Model Nos LLLD19HAmerican Contract Systems, Inc.MLS
Z-1337-2025Class IILAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02American Contract Systems, Inc.FDE
Z-1336-2025Class IIC-SECTION PACK, Model Nos LLCS44F LLCS44F-01American Contract Systems, Inc.OHM
Z-1335-2025Class IICYSTO PACK , Model N. HKCY31AAmerican Contract Systems, Inc.NWU
Z-1334-2025Class IIMAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HAmerican Contract Systems, Inc.LRO
Z-1333-2025Class IIHIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02American Contract Systems, Inc.OJH
Z-1332-2025Class IIDR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01American Contract Systems, Inc.LRO
Z-1331-2025Class IILAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GAmerican Contract Systems, Inc.FDE
Z-1460-2025Class IIMedline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-1387-2025Class IIDxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI...Siemens Healthcare Diagnostics Inc.JJE
Z-1295-2025Class IIAURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator...Integra LifeSciences CorporationGWG
Z-1375-2025Class IIBD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower...CareFusion 303, IncBRY
Z-2569-2025Class IIMEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH)...Medical Information Technology, Inc.JQP
Z-1254-2025Class IBaxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Baxter Healthcare CorporationFRN
Z-1253-2025Class IBaxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAXBaxter Healthcare CorporationFRN
Z-1306-2025Class IAortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model...Medtronic Perfusion SystemsDWF
Z-1208-2025Class IIIntelePACS (Image Fusion Module) - InteleViewerIntelerad Medical Systems IncorporatedLLZ
Z-1388-2025Class IIDxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.Siemens Healthcare Diagnostics Inc.JJE
Z-1386-2025Class IIAccess 2 Immunoassay Analyzer, Catalog Number 81600NSiemens Healthcare Diagnostics Inc.JJE
Z-1244-2025Class IRotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF...Bard Peripheral Vascular IncMCW
Z-1406-2025Class IICRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.American Contract Systems, Inc.OJG
Z-1391-2025Class IIIsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog...Boston Scientific CorporationPCT
Z-2323-2025Class IIHemosIL LMW Heparin Controls; Part Number: 0020300200;Instrumentation Laboratory Co.KFF
Z-1427-2025Class IICardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model...Abbott MedicalMOM
Z-1249-2025Class IIAccess Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons)...Siemens Healthcare Diagnostics Inc.GGT
Z-1250-2025Class IIBrand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x /...Medimaps Group SAKGI
Z-1196-2025Class IVOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF...Ventec Life Systems, Inc.CBK
Z-1232-2025Class IILIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in...Physio Control, Inc.MKJ
Z-1426-2025Class IIBrand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab...American Contract Systems, Inc.OES
Z-1425-2025Class IIBrand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number...American Contract Systems, Inc.FDE
Z-1424-2025Class IIBrand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number...American Contract Systems, Inc.NWU
Z-1243-2025Class IISIGNA MR380, NMRI system, Non-US OnlyGE Healthcare (China) Co., Ltd.LNH
Z-1242-2025Class IISIGNA MR355, SIGNA MR360, NMRI systemGE Healthcare (China) Co., Ltd.LNH
Z-1241-2025Class IIOptima MR360, NMRI systemGE Healthcare (China) Co., Ltd.LNH
Z-1240-2025Class IIBrivo MR355, NMRI systemGE Healthcare (China) Co., Ltd.LNH
Z-1239-2025Class IISIGNA Creator, SIGNA Explorer, NMRI systemsGE Healthcare (China) Co., Ltd.LNH
Z-1291-2025Class IIDeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing...DeRoyal Industries, Inc.GAZ
Z-1312-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps...Aesculap IncKAE
Z-1311-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD...Aesculap IncHXD
Z-1310-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps...Aesculap IncHTD