FDAMay 15, 2023device
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
What to do
FDA enforcement status: Ongoing
Brands named
olympus
UPCs
0081568602055205010210512
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21122026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21112026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.2026-03-25
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