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Stop using now Medical device recall · FDA · Published January 2, 2019

Leica M220 F12 Surgical Microscope Recall: Risk of Dropping Into Surgical Field

Leica Microsystems recalls M220 F12 surgical microscopes due to risk of unintended drops into surgical field. Affected units have specific serial numbers. Contact Leica for details.

🇺🇸 FDA recall #Z-0772-2019Medical deviceLeica ›
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Contact the company

Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
✎ GovInfoNow plain-language explainer

Leica Microsystems is recalling its M220 F12 surgical microscopes because the optics could unintentionally drop into the surgical field, potentially contacting the patient. This recall affects specific serial numbers and requires immediate attention to prevent injury. Read more at govinfonow.com/recall/69192-leica-m220-f12-surgical-microscope-recall-risk-of-dropping-into.

Source Summary by GovInfoNow · govinfonow.com/recall/69192-leica-m220-f12-surgical-microscope-recall-risk-of-dropping-into · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0772-2019

Cite this page

“Leica M220 F12 Surgical Microscope Recall: Risk of Dropping Into Surgical Field.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69192-leica-m220-f12-surgical-microscope-recall-risk-of-dropping-into. Based on FDA recall #Z-0772-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0772-2019%22&limit=1).

The FDA announced on 2019-01-02 that Leica Microsystems, Inc. is recalling the Leica M220 F12 surgical microscope because its optics may unintentionally drop into the surgical field, risking contact with the patient.

How to tell if you have it

  • Brand: Leica
  • Product: Leica M220 F12 surgical microscope
  • Serial Numbers: 10448367-60618002, 10448367-150317002, 10448367-40518001, 10448367-170417002, 10448367-80517001, 10448367-131117001, 10448367-271117001, 10448367-91017002, 10448367-220318003, 10448367-61017001, 10448367-171117001, 10448367-90418001, 10448367-170417001, 10448367-20418001, 10448367-170718002
  • Units affected: 15

The hazard

The M220 optics 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 2017-06-19. Other recent recalls of similar products include Katalyst Surgical DEX Ophthalmic Tissue Forceps Recall (2026-03-25), Canon Alphenix INFX-8000C/B5 Recall (2026-08-26), and Olympus HX-400U-30 Ligating Device Recall (2025-10-30).

How to tell if you have this one

Check if your microscope has a serial number starting with 10448367 followed by 8-10 digits. The affected models are listed in the recall notice.

  • Brand
    Leica
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using It Now

    Immediately cease using the Leica M220 F12 microscope if you have the affected serial numbers.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution: US (nationwide) and countries of: Albania, Algeria, Armenia, Argentina, Bangladesh, Brazil, Burundi, Canada, China, Colombia, Egypt, France, Germany, Guatemala, India, Indonesia, Japan, Nepal, Netherlands, New…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Jan 2, 201912. FDA classified it Class II: Jan 24, 201923. Published in FDA’s Enforcement Report: Jan 30, 201934. FDA terminated the recall: Apr 2, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What serial numbers are affected?

Serial numbers starting with 10448367 followed by 8-10 digits: 10448367-60618002, 10448367-150317002, 10448367-40518001, 10448367-170417002, 10448367-80517001, 10448367-131117001, 10448367-271117001, 10448367-91017002, 10448367-220318003, 10448367-61017001, 10448367-171117001, 10448367-90418001, 10448367-170417001, 10448367-20418001, 10448367-170718002.

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Where this comes from

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-0772-2019 (January 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0772-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA