Use cautionMedical device recall · FDA · Published June 9, 2021
Olympus Gyrus Acmi PKS Omni 5mm/3: Risk of tissue burn from failed adhesive
Olympus recalls Gyrus Acm: PKS Omni 5mm/33cm surgical tools due to expired adhesive causing potential tissue burns. Affected units sold with Gyrus ACMI G400 workstation.
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610
“Olympus Gyrus Acmi PKS Omni 5mm/3: Risk of tissue burn from failed adhesive.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62364-olympus-gyrus-acmi-pks-omni-5mm-3-risk-of-tissue. Based on FDA recall #Z-2380-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2380-2021%22&limit=1).
The FDA announced on June 9, 2021, that Olympus Corporation of the Americas is recalling Gyrus Acmi PKS Omni 5mm/33cm electrosurgical devices due to failed adhesive. The hazard involves potential foreign body reactions or tissue burns to patients.
How to tell if you have it
Brand: Olympus
Product: Gyrus Acmi PKS Omni 5mm/33cm
Ref: 970010PC
Lot number: KR121617
Quantity: 30 units (6 boxes of 5 per box)
Sold in CA, GA, MN, TN
The hazard
Expired adhesive used as an electrical insulation barrier and secondary retention bond failed. This could result in a foreign body or biologic reaction within the patient and/or electrical continuity causing tissue burn to critical structures.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Recent similar recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable recall on August 27, 2026, and an Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall on August 24, 2026. Other recent recalls of similar products include an Olympus OER-Pro recall on October 31, 2025, an I.T.S. GmbH FR.O.H. Calcaneus Repair System recall on January 23, 2026, and a Wilson-Cook Instinct Plus Endoscopic Clipping Device recall on March 3, 2026.
How to tell if you have this one
Check for the product name 'Gyrus Acmi PKS Omni 5mm/33cm' and lot number KR121617. The tools were sold with the Gyrus ACMI G400 workstation.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and lot number to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, GA, MN, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Minnesota, Tennessee.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2380-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2380-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.