Use cautionMedical device recall · FDA · Published November 3, 2021
Leica M220 F12 Microscope Systems Recall: Risk of Unintentional Patient Contact
Leica recalls M220 F12 Surgical Microscope systems due to potential risk of optics carrier dropping into surgical field. Affected units have specific serial numbers; contact Leica for details.
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Take action
Contact the company
📍Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
“Leica M220 F12 Microscope Systems Recall: Risk of Unintentional Patient Contact.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61595-leica-m220-f12-microscope-systems-recall-risk-of-unintentional-patient. Based on FDA recall #Z-0412-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0412-2022%22&limit=1).
Leica Microsystems, Inc. recalled Leica Microsystems M220 F12 Microscope Systems on Nov. 3, 2021, according to the FDA. The optics carrier may unintentionally drop into the surgical field, risking contact with patients. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Leica
Product: Leica Microsystems M220 F12 Microscope Systems
In May 2021, Leica Microsystems received one complaint regarding the M220 F12 Surgical Microscope system. No patient injury was reported for this complaint. The defect carries potential injury risk as the optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Context
GovInfoNow's records show Leica Microsystems, Inc. has 15 other recalls on record since June 19, 2017. Other recent recalls of similar products include Leica Provido Surgical Microscope Recall (Nov. 21, 2022), Leica Surgical Microscopes M530 OHX (Aug. 26, 2022), and Leica BOND Antibody CDX2 Recall (July 30, 2021). Other recent recalls of similar products include Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025), GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), and Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026).
How to tell if you have this one
Check for serial numbers listed in the recall notice: U.S. serial numbers start with 180709002 and similar patterns, and Canada serial numbers follow a different format. The product is a surgical microscope system.
Brand
Leica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Numbers
Compare your serial number to the list of affected U.S. and Canada serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, DC, FL, GA, IL, IN, MA, MI, MD, NY, OH, OR, PA, TN, TX, VA, WI, and Puerto Rico. The countries of Albania, Algeria, Argentina, Armenia, Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years 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-0412-2022 (November 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0412-2022 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.