510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 194 of 1190
FDA device recalls, page 194 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2107-2023Class IIREF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileOsteomedGWO
Z-2038-2023Class IIRemel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus...Remel IncJSO
Z-2138-2023Class IICOULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cellsSiemens Healthcare Diagnostics Inc.GIF
Z-1498-2024Class IIFemoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO...Synovo ProductionKXB
Z-1497-2024Class IIACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers...Synovo ProductionKXB
Z-1496-2024Class IIACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY...Synovo ProductionKXB
Z-0613-2024Class IIAlinity ci-series System Control Module, REF: 03R70-01Abbott MedicalJJE
Z-2247-2023Class IIVERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)Advanced Medical Optics, Inc.HQC
Z-2127-2023Class IIGE Healthcare Vivid S70N, ultrasound deviceGE Vingmed Ultrasound ASIYN
Z-2126-2023Class IIGE Healthcare Vivid S60N, ultrasound deviceGE Vingmed Ultrasound ASIYN
Z-2125-2023Class IIGE Healthcare Vivid S70, ultrasound deviceGE Vingmed Ultrasound ASIYN
Z-2124-2023Class IIGE Healthcare Vivid S60, ultrasound deviceGE Vingmed Ultrasound ASIYN
Z-2010-2023Class IIREF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RLimacorporate S.p.A.MBF
Z-2009-2023Class IIREF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RLimacorporate S.p.A.MBF
Z-2090-2023Class IICustom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102...DeRoyal Industries, Inc.OEQ
Z-2089-2023Class IICustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219DeRoyal Industries, Inc.MLT
Z-2088-2023Class IICustom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF...DeRoyal Industries, Inc.KDD
Z-2087-2023Class IICustom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF...DeRoyal Industries, Inc.FNY
Z-2086-2023Class IICustom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941...DeRoyal Industries, Inc.LRO
Z-2344-2023Class IIOlympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection...OLYMPUS Corporation of the AmericasFEB
Z-2343-2023Class IIOlympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of...OLYMPUS Corporation of the AmericasFEB
Z-2342-2023Class IIOlympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of...OLYMPUS Corporation of the AmericasFEB
Z-2341-2023Class IITracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source...OLYMPUS Corporation of the AmericasEOQ
Z-2340-2023Class IIVISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which...OLYMPUS Corporation of the AmericasEOQ
Z-2128-2023Class IIAbiomed 14Fr Low Profile Introducer Set, Product Number 1000457Abiomed, Inc.DYB
Z-2234-2023Class IIFlexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that...Boston Scientific CorporationGEX
Z-2233-2023Class IIFlexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits...Boston Scientific CorporationGEX
Z-2232-2023Class IIFlexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from...Boston Scientific CorporationGEX
Z-2231-2023Class IIFlexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from...Boston Scientific CorporationGEX
Z-2230-2023Class IIFlexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that...Boston Scientific CorporationGEX
Z-2229-2023Class IIFlexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that...Boston Scientific CorporationGEX
Z-2228-2023Class IIFlexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits...Boston Scientific CorporationGEX
Z-2106-2023Class IITrilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853)...Respironics, Inc.CBK
Z-1974-2023Class IQuidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and...Quidel Cardiovascular Inc.MMI
Z-2097-2023Class IIPilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractorTeleflex MedicalGAD
Z-2096-2023Class IIPilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractorTeleflex MedicalGAD
Z-2095-2023Class IIPilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractorTeleflex MedicalKAL
Z-1905-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055Teleflex MedicalBTR
Z-1904-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040Teleflex MedicalBTR
Z-1903-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035Teleflex MedicalBTR
Z-1902-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030Teleflex MedicalBTR
Z-1901-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025Teleflex MedicalBTR
Z-1900-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020Teleflex MedicalBTR
Z-1899-2023Class IRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045Teleflex MedicalBTR
Z-1898-2023Class IRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040Teleflex MedicalBTR
Z-1897-2023Class IRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035Teleflex MedicalBTR
Z-1896-2023Class IRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030Teleflex MedicalBTR
Z-1895-2023Class IRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025Teleflex MedicalBTR
Z-1894-2023Class IEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100Teleflex MedicalBTR
Z-1893-2023Class IEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095Teleflex MedicalBTR