Leica M220 F12 Surgical Microscope Optics Carrier May Drop Into Surgical Field
Leica Microsystems is recalling 2,800 M220 F12 surgical microscopes because the optics carrier may unintentionally drop into the surgical field, risking patient contact. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported patient injuries; the source explicitly states 'there was no patient injury reported' and the hazard is described as 'potential injury risk.' Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Leica Microsystems, Inc. is recalling 2,800 M220 F12 Surgical Microscope Systems worldwide. The optics carrier in these systems may unintentionally drop into the surgical field during use, potentially contacting a patient.
In May 2021, Leica received one complaint regarding this defect. No patient injuries have been reported, but the potential for harm during surgical procedures prompted the recall.
The affected microscopes were distributed worldwide, including throughout the United States and internationally. If you operate or maintain one of these systems, contact Leica Microsystems for further information regarding this safety issue.
The recalled product
- Product
- Leica Microsystems M220 F12 Microscope Systems
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- equipment-drop
- contact-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedline Suturing Set with Lidocaine Ampules Recalled
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
FDA (Devices) · 2026-07-08
- ModerateZeiss Intrabeam Spherical Applicator failed manufacturing specifications
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- ModeratePowerMidline Catheters Recalled for Deficient Manufacturing Practices
FDA (Devices) · 2026-07-08