Leica Microsystems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0412-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Leica Microsystems M220 F12 Microscope Systems

Product Classification:

Class II

Date Initiated: November 3, 2021

Date Posted: December 29, 2021

Recall Number: Z-0412-2022

Event ID: 89009

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,800

Code Information:

Part #: 10448367 UDI #: 07630003552188 U.S. Serial #'s: 180709002, 191109001, 261016002, 250815001, 280813001, 251111006, 61209001, 260810003, 240815001, 171116001, 190815001, 151209004, 261016001, 70715001, 60713002, 140510004, 180712001, 300910003, 161013001, 270612001, 140510005, 250512002, 10712002, 130913001, 51112001, 290414001, 260311001, 180515001, 270813001, 231014001, 110614001, 210814001, 180515002, 111212001, 270812001, 100614001, 171214002, 290514003, 101212001, 291013001, 50614002, 81012001, 30514001, 101212002, 40611002, 50614003, 171116002, 200314001, 170212001, 30311002, 150211001, 130913002, 60210005, 100212001, 290509001, 111113001, 120615003, 100212002, 300411006, 110315001, 210612002, 100212003, 210612001, 30614001, 20816001, 100212004, 260816001, 260816002, 291113001, 100212005, 21109002, 260811001, 100810004, 90112002 Canada Serial #'s: 260311010, 240414001, 70414002

Distribution Pattern:

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, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Canada, Chile, China, Colombia, Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Georgia, Great Britain, Greece, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, South Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, North Macedonia, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated