Z-0772-2019Class II

Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for...

Name: Z-0772-2019 Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for...
Creator: Leica Microsystems, Inc.
Published: 2019-01-02
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2019-01-02 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through... on 2019-01-02. FDA classified it as Class II and gives the reason as "The M220 optics may unintentionally drop into the surgical field, risking contact with the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0772-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-02
Posted: 2019-01-24
Terminated: 2021-04-02
Recalling firm: Leica Microsystems, Inc.
Product: 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.
Product code: HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Reason for recall: The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Leica, disseminated an "URGENT FIELD SAFETY NOTICE" dated 12/18/2018 on 01/02/2019 to its customers. The notice described the product, problem and actions to be taken. The notice directed the user to inspect the device for a gap between the black adapter and the white housing or a free rotation of the optics carrier for more 360o. If either are noted, the device could not be used. If you have any questions, contact the Clinical & Scientific Affairs Specialist at 847-876-5705 or email to: [email protected].
Quantity in commerce: 15 units
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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0772-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24

Product code HRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)