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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 481–500 of 1,000 recalls

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Orthorebirth Co Ltd

Resorbable bone void filler falls outside standard specifications.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Orthorebirth Co Ltd

Resorbable bone void filler falls outside standard specifications.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

Davol, Inc.

Potential for product to contain foreign matter, confirmed to be inspect fragments.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

Katalyst Surgical, LLC

Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

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