FDA.reportPublic FDA data

Recalls

Recall, Firm, Product code table
RecallFirmProduct codeStatusInitiatedPostedRoot cause / class
Z-0002-2027Instrumentation LaboratoryLCOOpen, Classified2026-09-032026-10-10Under Investigation by firm
Z-0001-2027Instrumentation LaboratoryLCOOpen, Classified2026-09-032026-10-10Under Investigation by firm
Z-0147-2027INTEGRATED MEDCRAFT LLCOHOOpen, Classified2026-09-252026-10-09Component change control
Z-0143-2027Boston Scientific CorporationFGEOpen, Classified2026-09-102026-10-09Under Investigation by firm
Z-0142-2027Neuronetics, Inc.OBPOpen, Classified2026-08-242026-10-09Nonconforming Material/Component
Z-0146-2027SI-BONE, Inc.OUROpen, Classified2026-08-212026-10-09Packaging
Z-0141-2027Cadwell Industries IncGWFOpen, Classified2026-08-182026-10-09Under Investigation by firm
Z-0140-2027Becton Dickinson & Co.LONOpen, Classified2026-08-132026-10-09Under Investigation by firm
Z-0139-2027Becton Dickinson & Co.LONOpen, Classified2026-08-132026-10-09Under Investigation by firm
Z-0138-2027Medtronic Sofamor Danek USA IncMBPOpen, Classified2026-08-122026-10-09Process change control
Z-0137-2027Medtronic Sofamor Danek USA IncMBPOpen, Classified2026-08-122026-10-09Process change control
Z-0136-2027Jenavalve Technology Inc.NPTOpen, Classified2026-07-312026-10-09Nonconforming Material/Component
Z-0135-2027Jenavalve Technology Inc.NPTOpen, Classified2026-07-312026-10-09Nonconforming Material/Component
Z-0134-2027Jenavalve Technology Inc.NPTOpen, Classified2026-07-312026-10-09Nonconforming Material/Component
Z-0144-2027Sarnova HC, LlcCCXOpen, Classified2026-06-122026-10-09Nonconforming Material/Component
Z-0145-2027Ferno-Washington IncFPOOpen, Classified2026-04-282026-10-09Software design
Z-0118-2027Steris CorporationFTAOpen, Classified2026-09-232026-10-07Software design
Z-0116-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0115-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0114-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0113-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0112-2027Mindray DS USA, Inc.MSXOpen, Classified2026-08-312026-10-07Labeling design
Z-0111-2027Mindray DS USA, Inc.MSXOpen, Classified2026-08-312026-10-07Labeling design
Z-0110-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0109-2027Mindray DS USA, Inc.MHXOpen, Classified2026-08-312026-10-07Labeling design
Z-0119-2027Intellijoint Surgical, Inc.OLOOpen, Classified2026-08-282026-10-07Nonconforming Material/Component
Z-0117-2027LeMaitre Vascular, Inc.DXEOpen, Classified2026-08-282026-10-07Under Investigation by firm
Z-0108-2027Canon Medical System, USA, INC.OWBOpen, Classified2026-08-262026-10-07Process control
Z-0107-2027POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCJPHOpen, Classified2026-08-252026-10-07Process control
Z-0106-2027AVID Medical, Inc.OKVOpen, Classified2026-08-102026-10-07Process change control
Z-0105-2027AVID Medical, Inc.OKVOpen, Classified2026-08-102026-10-07Process change control
Z-0104-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0103-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0102-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0101-2027AVID Medical, Inc.OKVOpen, Classified2026-08-102026-10-07Process change control
Z-0100-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0099-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0098-2027AVID Medical, Inc.OEZOpen, Classified2026-08-102026-10-07Process change control
Z-0097-2027AVID Medical, Inc.OEZOpen, Classified2026-08-102026-10-07Process change control
Z-0096-2027AVID Medical, Inc.OJGOpen, Classified2026-08-102026-10-07Process change control
Z-0095-2027AVID Medical, Inc.OEZOpen, Classified2026-08-102026-10-07Process change control
Z-0094-2027AVID Medical, Inc.OEZOpen, Classified2026-08-102026-10-07Process change control
Z-0093-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0092-2027AVID Medical, Inc.LROOpen, Classified2026-08-102026-10-07Process change control
Z-0089-2027Nihon Kohden America LLCMHXOpen, Classified2026-09-082026-10-06Software design
Z-0091-2027Onkos Surgical, Inc.LPHOpen, Classified2026-07-242026-10-06Labeling mix-ups
Z-0090-2027Onkos Surgical, Inc.LPHOpen, Classified2026-07-242026-10-06Labeling mix-ups
Z-0088-2027Medtronic MiniMed, Inc.QFGOpen, Classified2026-08-202026-10-05Under Investigation by firm
Z-0085-2027Stryker Sustainability SolutionsNLHOpen, Classified2026-08-182026-10-05Packaging process control
Z-0087-2027Medline Industries, LPITJOpen, Classified2026-08-142026-10-05Process control
Z-0086-2027Medline Industries, LPITJOpen, Classified2026-08-142026-10-05Process control
Z-0084-2027Beckman Coulter Inc.JJEOpen, Classified2026-09-022026-10-02Software design
Z-0083-2027Beckman Coulter Inc.JJEOpen, Classified2026-09-022026-10-02Software design
Z-0081-2027Safeguard US Operating LLCMHWOpen, Classified2026-09-022026-10-02Component change control
Z-0075-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm
Z-0074-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm
Z-0073-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm
Z-0072-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm
Z-0071-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm
Z-0070-2027Steris CorporationFRCOpen, Classified2026-08-312026-10-02Under Investigation by firm