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 103 of 1190
FDA device recalls, page 103 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0999-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0998-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0997-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0996-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0995-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0994-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0993-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0809-2025Class IIXhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide...GE HealthcareMHX
Z-0810-2025Class IIXhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring...GE HealthcareMHX
Z-0680-2025Class IITurbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product...Spectranetics Corp.MCW
Z-0685-2025Class IIEclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive...GE HealthcareMWJ
Z-0684-2025Class IIEclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter...GE HealthcareMWJ
Z-0770-2025Class IIAURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100Boston Scientific CorporationMCW
Z-0970-2025Class IIOtological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;Adept Medical LtdETD
Z-0969-2025Class IIOtological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;Adept Medical LtdETD
Z-0968-2025Class IIOtological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;Adept Medical LtdETD
Z-0967-2025Class IIOtological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;Adept Medical LtdETD
Z-0966-2025Class IIOtological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;Adept Medical LtdETD
Z-0965-2025Class IIOtological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;Adept Medical LtdETD
Z-0964-2025Class IIOtological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;Adept Medical LtdETD
Z-0963-2025Class IIOtological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;Adept Medical LtdETD
Z-0834-2025Class IICook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, SterileCook Biotech, Inc.GXQ
Z-0833-2025Class IICook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andCook Biotech, Inc.OWV
Z-0832-2025Class IICook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285...Cook Biotech, Inc.KHJ
Z-0820-2025Class IICitric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25Nipro Renal Solutions USA, CorporationKPO
Z-0743-2025Class IIClarity Precision Grip Attachments, for use in orthodontic treatment. Part...3M CompanyNXC
Z-0741-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0740-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0739-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0738-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0737-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0736-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0735-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0734-2025Class IIepoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number...Siemens Healthcare Diagnostics Inc.CHL
Z-0794-2025Class IIMedline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0793-2025Class IIMedline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-0792-2025Class IIMedline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0791-2025Class IIMedline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LFMEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-0790-2025Class IISee DocManMEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-0789-2025Class IIMedline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-0788-2025Class IISee DocManMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0787-2025Class IIMedline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-0786-2025Class IIMedline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0785-2025Class IIMedline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-0784-2025Class IIMedline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-0783-2025Class IIMedline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0782-2025Class IISee DocManMEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-0781-2025Class IIMedline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.MEDLINE INDUSTRIES, LP - NorthfieldMMO
Z-0780-2025Class IIMedline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-0779-2025Class IIMedline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFF