Class IIOngoingZ-1903-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
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Olympus Corporation of…PAApr 29, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 649–660 of 3,866 recalls
Class IIOngoingZ-1902-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1901-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1900-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1899-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1898-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. Ma…
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1897-2026
XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute…
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
XTANT Medical Holdings…MTApr 29, 2026
Class IIOngoingZ-1896-2026
Davol, Inc. recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number…
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Davol, Inc.RIApr 29, 2026
Class IIOngoingZ-1895-2026
Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Magellan Diagnostics,…MAApr 29, 2026
Class IIOngoingZ-1894-2026
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Magellan Diagnostics,…MAApr 29, 2026
Class IIOngoingZ-1893-2026
Magellan Diagnostics, Inc. recalls (1)(2) LeadCare¿ II Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Magellan Diagnostics,…MAApr 29, 2026
Class IIOngoingZ-1892-2026
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Industries, LPILApr 29, 2026