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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

59,476 records, page 208 of 1190
FDA device recalls, page 208 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1395-2023Class IIGEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint...Gramercy Extremity Orthopedics, LLC.HRS
Z-1462-2023Class IIMAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32Datascope Corp.DSP
Z-2636-2023Class IIProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning DeviceJ&T Health and Wellness LLCLEJ
Z-1594-2023Class IPilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number...SD Biosensor, Inc.QKP
Z-1616-2023Class IIITo be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA)...OLYMPUS Corporation of the AmericasFCG
Z-1615-2023Class IIIViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for...OLYMPUS Corporation of the AmericasFCG
Z-1571-2023Class IIPDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A...Ethicon, IncNEW
Z-1583-2023Class IIgreiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24...Greiner Bio-One North America, Inc.JKA
Z-1482-2023Class IIHill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S...Baxter Healthcare CorporationIOQ
Z-1703-2023Class IIMedicine Dropper, Product Code K508Apothecary Products, LLCKCM
Z-1702-2023Class IIEye and Ear Dropper, Product Code 67082Apothecary Products, LLCKCM
Z-1626-2023Class IIbinx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia...Binx Health, Inc.QEP
Z-0693-2024Class IDistal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or...Percussionaire Corp.CBK
Z-2227-2023Class IIDYND3000xxP Series - Flexible Laryngeal Mask Airway PacksMEDLINE INDUSTRIES, LP - NorthfieldCAE
Z-1602-2023Class IIYelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileRSurgical Innovations LtdGCJ
Z-1601-2023Class IIYelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileRSurgical Innovations LtdGCJ
Z-1502-2023Class IICentricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009...GE HealthcareLLZ
Z-1501-2023Class IICentricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers...GE HealthcareLLZ
Z-1500-2023Class IICentricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b)...GE HealthcareLLZ
Z-1573-2023Class IITDHisto/Cyto - A software product used for managing medical information in the field of...TechnidataJQP
Z-1617-2023Class IIOmnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures...Omnicell, Inc.NEP
Z-1603-2023Class IIImmundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for...Immundiagnostik AGDEG
Z-1393-2023Class IIJourney II Uni Xlpe Tibia Insert Medial Sz 7-8 8MmSmith & Nephew, Inc.HSX
Z-1461-2023Class IIGEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a)...Baxter Healthcare CorporationJXI
Z-1496-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RECordis US Corp.NTE
Z-1495-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCordis US Corp.NTE
Z-1494-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCordis US Corp.NTE
Z-1493-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RECordis US Corp.NTE
Z-1492-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RECordis US Corp.NTE
Z-1491-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECordis US Corp.NTE
Z-1490-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCordis US Corp.NTE
Z-1489-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECCordis US Corp.NTE
Z-1488-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MCCordis US Corp.NTE
Z-1487-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMCCordis US Corp.NTE
Z-1486-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMCCordis US Corp.NTE
Z-1485-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCCordis US Corp.NTE
Z-1484-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCCordis US Corp.NTE
Z-1425-2023Class IIFLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685Richard Wolf GmbHFCL
Z-1424-2023Class IIFLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685Richard Wolf GmbHFCL
Z-1423-2023Class IIFLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051Richard Wolf GmbHFCL
Z-1422-2023Class IIFLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051Richard Wolf GmbHFCL
Z-1357-2023Class IShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable...Medtronic, Inc.JOH
Z-1483-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCCordis US Corp.NTE
Z-1499-2023Class IIWALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping...Aso LLCKGX
Z-1568-2023Class IASM Replacement Battery, Component Number SUB0000594Abbott MedicalFRN
Z-1567-2023Class IASM Replacement Battery, Component Number SUB0000864Abbott MedicalFRN
Z-1577-2023Class IISTA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612Diagnostica Stago, Inc.JPA
Z-1576-2023Class IISTA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612Diagnostica Stago, Inc.JPA
Z-1575-2023Class IISTA R Max fully automatic clinical instrument designed to perform tests on human plasmas...Diagnostica Stago, Inc.JPA
Z-1465-2023Class IIVersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STSMedtronic, Inc.GCJ