FDA.reportPublic FDA data

Recalls

Recall, Firm, Product code table
RecallFirmProduct codeStatusInitiatedPostedRoot cause / class
Z-3113-2026Atrium Medical CorporationGBZOpen, Classified2026-08-072026-09-04Nonconforming Material/Component
Z-3112-2026Atrium Medical CorporationGBZOpen, Classified2026-08-072026-09-04Nonconforming Material/Component
Z-3111-2026Atrium Medical CorporationGBZOpen, Classified2026-08-072026-09-04Nonconforming Material/Component
Z-3110-2026Lutronic CorporationGEXOpen, Classified2026-08-062026-09-04Device Design
Z-3120-2026HeartSine Technologies LtdMKJOpen, Classified2026-07-272026-09-04Process control
Z-3109-2026AVID Medical, Inc.LROOpen, Classified2026-07-142026-09-04Packaging process control
Z-3119-2026C.R. Bard IncKNXOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3118-2026C.R. Bard IncKNXOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3117-2026C.R. Bard IncKODOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3116-2026C.R. Bard IncMJCOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3115-2026C.R. Bard IncEZLOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3114-2026C.R. Bard IncEZCOpen, Classified2026-06-252026-09-04Under Investigation by firm
Z-3105-2026Cardinal Health 200, LLCOJHOpen, Classified2026-07-292026-09-03Process change control
Z-3104-2026Cardinal Health 200, LLCOJGOpen, Classified2026-07-292026-09-03Process change control
Z-3103-2026Cardinal Health 200, LLCOJFOpen, Classified2026-07-292026-09-03Process change control
Z-3102-2026Cardinal Health 200, LLCOHMOpen, Classified2026-07-292026-09-03Process change control
Z-3101-2026Cardinal Health 200, LLCOHDOpen, Classified2026-07-292026-09-03Process change control
Z-3100-2026Cardinal Health 200, LLCOGROpen, Classified2026-07-292026-09-03Process change control
Z-3099-2026Cardinal Health 200, LLCOFXOpen, Classified2026-07-292026-09-03Process change control
Z-3098-2026Cardinal Health 200, LLCOEZOpen, Classified2026-07-292026-09-03Process change control
Z-3097-2026Cardinal Health 200, LLCNWUOpen, Classified2026-07-292026-09-03Process change control
Z-3096-2026Cardinal Health 200, LLCLRPOpen, Classified2026-07-292026-09-03Process change control
Z-3095-2026Cardinal Health 200, LLCLROOpen, Classified2026-07-292026-09-03Process change control
Z-3094-2026Cardinal Health 200, LLCFDEOpen, Classified2026-07-292026-09-03Process change control
Z-3093-2026Fresenius Medical Care Renal Therapies Group, LLCKPOOpen, Classified2026-07-142026-09-03Material/Component Contamination
Z-3092-2026Fresenius Medical Care Renal Therapies Group, LLCKPOOpen, Classified2026-07-142026-09-03Material/Component Contamination
Z-3091-2026Fresenius Medical Care Renal Therapies Group, LLCKPOOpen, Classified2026-07-142026-09-03Material/Component Contamination
Z-3087-2026Fresenius Medical Care Renal Therapies Group, LLCKOCOpen, Classified2026-08-102026-09-02Component change control
Z-3086-2026Fresenius Medical Care Renal Therapies Group, LLCKOCOpen, Classified2026-08-102026-09-02Component change control
Z-3085-2026Fresenius Medical Care Renal Therapies Group, LLCKOCOpen, Classified2026-08-102026-09-02Component change control
Z-3084-2026Fresenius Medical Care Renal Therapies Group, LLCKOCOpen, Classified2026-08-102026-09-02Component change control
Z-3083-2026Boston Scientific CorporationMXDOpen, Classified2026-08-062026-09-02Software design
Z-3082-2026Boston Scientific CorporationMXDOpen, Classified2026-08-062026-09-02Software design
Z-3081-2026Boston Scientific CorporationMXDOpen, Classified2026-08-062026-09-02Software design
Z-3089-2026B Braun Medical IncFPAOpen, Classified2026-08-042026-09-02Under Investigation by firm
Z-3088-2026Medos International SarlOLOOpen, Classified2026-07-232026-09-02Under Investigation by firm
Z-3043-2026Philips North America LlcJAKOpen, Classified2026-08-072026-09-01Radiation Control for Health and Safety Act
Z-3042-2026Philips North America LlcJAKOpen, Classified2026-08-072026-09-01Radiation Control for Health and Safety Act
Z-3041-2026Philips North America LlcJAKOpen, Classified2026-08-072026-09-01Radiation Control for Health and Safety Act
Z-3040-2026Philips North America LlcJAKOpen, Classified2026-08-072026-09-01Radiation Control for Health and Safety Act
Z-3066-2026Baxter Healthcare CorporationFRNOpen, Classified2026-08-112026-08-31Software design
Z-3065-2026Baxter Healthcare CorporationFRNOpen, Classified2026-08-112026-08-31Software design
Z-3064-2026Johnson & Johnson Surgical Vision, Inc.LZPOpen, Classified2026-07-312026-08-31Device Design
Z-3079-2026Medline Industries, LPOJHOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3078-2026Medline Industries, LPOJKOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3077-2026Medline Industries, LPOHMOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3076-2026Medline Industries, LPMLSOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3075-2026Medline Industries, LPNSBOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3074-2026Medline Industries, LPOJUOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3073-2026Medline Industries, LPOIBOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3072-2026Medline Industries, LPMCYOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3071-2026Medline Industries, LPLRSOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3070-2026Medline Industries, LPLROOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3069-2026Medline Industries, LPKDDOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3068-2026Medline Industries, LPOEZOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3067-2026Medline Industries, LPOFTOpen, Classified2026-07-202026-08-31Nonconforming Material/Component
Z-3063-2026Medline Industries, LPOIBOpen, Classified2026-06-122026-08-31Nonconforming Material/Component
Z-3062-2026Medline Industries, LPOJHOpen, Classified2026-06-122026-08-31Nonconforming Material/Component
Z-3061-2026Medline Industries, LPOJKOpen, Classified2026-06-122026-08-31Nonconforming Material/Component
Z-3060-2026Medline Industries, LPOHMOpen, Classified2026-06-122026-08-31Nonconforming Material/Component