Class IIOngoingZ-3047-2026
Diagnostica Stago, Inc. recalls STA Staclot Protein S
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Diagnostica Stago, Inc…NJSep 9, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 109–120 of 674 recalls
Class IIOngoingZ-3032-2026
Healthmark Industries Co., Inc. recalls healthmark ProChek-W Protein Test for Robotic Arms
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Healthmark Industries…MISep 2, 2026
Class IIOngoingZ-3031-2026
Healthmark Industries Co., Inc. recalls healthmark ProChek-II
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Healthmark Industries…MISep 2, 2026
Class IIOngoingZ-2993-2026
Medline Industries, LP recalls Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localiz…
Medline Industries, LPILSep 2, 2026
Class IIOngoingZ-2992-2026
Medline Industries, LP recalls Medline breathing circuits labeled as: 1) HUDSON RCI
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localiz…
Medline Industries, LPILSep 2, 2026
Class IIOngoingZ-2991-2026
Medline Industries, LP recalls Medline Hudson RCI
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localiz…
Medline Industries, LPILSep 2, 2026
Class IOngoingZ-2978-2026
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific Corp…MNAug 26, 2026
Class IOngoingZ-2977-2026
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific Corp…MNAug 26, 2026
Class IIIOngoingZ-2972-2026
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.COAug 26, 2026
Class IIIOngoingZ-2971-2026
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.COAug 26, 2026
Class IIOngoingZ-2966-2026
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthcare Dia…Aug 26, 2026
Class IIOngoingZ-2965-2026
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981…
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthcare Dia…Aug 26, 2026