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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 161–180 of 1,000 recalls

Class IOngoing

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Ventec Life Systems, Inc.

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

March 25, 2026 · DeviceView details →
Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

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-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 IIIOngoing

Heraeus, PALAMIX duo. Material Number: 66057897.

Heraeus Medical GmbH (Dental Division)

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

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 →
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