CLASS II Device recall · Reported 30 Jan 2019 · FDA Enforcement Report

Leica M220 F12 surgical microscope The Leica M220 F12 recalled

Leica Microsystems is recalling Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical, distributed nationwide in the US. The recall was initiated on 2 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0772-2019
FDA event ID: 81903
Recalling firm: Leica Microsystems, Buffalo Grove, IL
Classification: Class II
Status: Terminated
Recall initiated: 2 Jan 2019
FDA classified: 24 Jan 2019
Reported: 30 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

2 Jan 2019	Recall initiated by company
24 Jan 2019	Classified by FDA	+22 days
30 Jan 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Product as listed by the FDA

Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

Where it was distributed

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 Zealand, Malaysia, Pakistan, Peru, Philippines, Poland, Qatar, Romania, Russia Federation, Saudi Arabia, Senegal, Spain, South Africa, South Korea, Switzerland, Tanzania, Thailand, Turkey, Ukraine, and Vietnam.

Nationwide

Questions about this recall

Is Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical recalled?

Yes. Leica Microsystems recalled Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical on 2 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-0772-2019.

Why was it recalled?

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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