CLASS II Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
M220 F12 Microscope Systems recalled by Leica Microsystems
Leica Microsystems is recalling M220 F12 Microscope Systems, distributed nationwide in the US. The recall was initiated on 3 Nov 2021 and the FDA has classified it as Class II.
Check your package
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-0412-2022
- FDA event ID
- 89009
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2021
- FDA classified
- 22 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2021 | Recall initiated by company | |
| 22 Dec 2021 | Classified by FDA | +49 days |
| 29 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Leica Microsystems M220 F12 Microscope Systems
Where it was distributed
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.
Nationwide CaliforniaDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaMassachusettsMarylandMichiganNew YorkOhioOregonPennsylvaniaPuerto RicoTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
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 26 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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