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 61 of 1190
FDA device recalls, page 61 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0221-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System...UIH Technologies LLCJAK
Z-0220-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System...UIH Technologies LLCJAK
Z-0219-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System...UIH Technologies LLCJAK
Z-0218-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System...UIH Technologies LLCJAK
Z-0217-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System...UIH Technologies LLCJAK
Z-0598-2026Class IIBrand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number...NOAH MEDICAL Corp.EOQ
Z-0303-2026Class IIStarcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0302-2026Class IISopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma...GE Medical Systems Israel, Functional ImagingKPS
Z-0301-2026Class IIOptima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0300-2026Class IIMillenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0299-2026Class IIMillenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0298-2026Class IIMillenium Myosight; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0297-2026Class IIMillenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0296-2026Class IIMaxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingGE Medical Systems Israel, Functional ImagingKPS
Z-0295-2026Class IIElscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0294-2026Class IIElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0293-2026Class IIElscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0292-2026Class IIElscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac...GE Medical Systems Israel, Functional ImagingKPS
Z-0291-2026Class IIElscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0290-2026Class IIElscint Cardial; dual-head nuclear medicine gamma camera designed specifically for...GE Medical Systems Israel, Functional ImagingKPS
Z-0589-2026Class IIOption"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The...Argon Medical Devices, IncDTK
Z-0166-2026Class IICardiac Workstation 7000; Model Number: 860441;Philips North America LLCDPS
Z-0165-2026Class IICardiac Workstation 5000; Model Number: 860439;Philips North America LLCDPS
Z-0205-2026Class IIProduct: STA Liatest D-Di; REF: 00515;Diagnostica Stago, Inc.DAP
Z-0227-2026Class IIiNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar...Theken Companies LLCMEH
Z-0234-2026Class IIExcelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number...MEDLINE INDUSTRIES, LP - NorthfieldNGT
Z-0147-2026Class IIECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or...Ethicon Endo-Surgery IncGDW
Z-0067-2026Class IOes Bronchofiberscope Olympus Bf Type Xt40OLYMPUS Corporation of the AmericasEOQ
Z-0066-2026Class IEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190OLYMPUS Corporation of the AmericasEOQ
Z-0065-2026Class IEvis Exera Bronchovideoscope Olympus Bf Type Xt160OLYMPUS Corporation of the AmericasEOQ
Z-0064-2026Class IBronchofiberscope Olympus Bf Type Te2OLYMPUS Corporation of the AmericasEOQ
Z-0063-2026Class IEvis Exera III Bronchovideoscope Olympus Bf-Q190OLYMPUS Corporation of the AmericasEOQ
Z-0062-2026Class IEvis Exera II Bronchovideoscope Olympus Bf Type Q180-AcOLYMPUS Corporation of the AmericasEOQ
Z-0061-2026Class IEvis Exera II Bronchovideoscope Olympus Bf Type Q180OLYMPUS Corporation of the AmericasEOQ
Z-0060-2026Class IBronchovideoscope Olympus Bf-Q170OLYMPUS Corporation of the AmericasEOQ
Z-0059-2026Class IBronchofiberscope Olympus Bf Type Pe2OLYMPUS Corporation of the AmericasEOQ
Z-0058-2026Class IOes Bronchofiberscope Olympus Bf Type P60OLYMPUS Corporation of the AmericasEOQ
Z-0057-2026Class IEvis Exera III Bronchovideoscope Olympus Bf-P190OLYMPUS Corporation of the AmericasEOQ
Z-0056-2026Class IEvis Exera II Bronchovideoscope Olympus Bf Type P180OLYMPUS Corporation of the AmericasEOQ
Z-0055-2026Class IBronchovideoscope Olympus Bf Type P150OLYMPUS Corporation of the AmericasEOQ
Z-0054-2026Class IOes Bronchofiberscope Olympus Bf Type Mp60OLYMPUS Corporation of the AmericasEOQ
Z-0053-2026Class IEvis Exera III Bronchovideoscope Olympus Bf-H190OLYMPUS Corporation of the AmericasEOQ
Z-0052-2026Class IBronchovideoscope Olympus Bf-H1100OLYMPUS Corporation of the AmericasEOQ
Z-0051-2026Class IEvis Exera II Bronchovideoscope Olympus Bf Type 1Tq180OLYMPUS Corporation of the AmericasEOQ
Z-0050-2026Class IBronchovideoscope Olympus Bf-1Tq170OLYMPUS Corporation of the AmericasEOQ
Z-0049-2026Class IEvis Exera III Bronchovideoscope Olympus Bf-1Th190OLYMPUS Corporation of the AmericasEOQ
Z-0048-2026Class IBronchovideoscope Olympus Bf-1Th1100OLYMPUS Corporation of the AmericasEOQ
Z-0047-2026Class IOes Bronchofiberscope Olympus Bf Type 1T60OLYMPUS Corporation of the AmericasEOQ
Z-0046-2026Class IEvis Exera II Bronchovideoscope Olympus Bf Type 1T180OLYMPUS Corporation of the AmericasEOQ
Z-0144-2026Class IILGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ)...Boston Scientific CorporationJCW