High FDA (Devices)·Z-0412-2022·Announced 2021-12-29

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.
Category: Medical Device — Surgical Microscope
Hazard: equipment-drop
contact-injury
Affected units: 2,800

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.

The notice also names 18 states specifically:

Same manufacturer · Leica Microsystems, Inc.

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Same hazard · equipment drop