Food, drugs, devices › Leica Microsystems, Inc.

Device recall: Leica M525 F20 Surgical Microscope System

FDA enforcement event 80979 · Class II · initiated 4 Sep 2018 · status Terminated · terminated 17 Aug 2021

DeviceVoluntary: Firm initiated1 product recordBuffalo Grove, IL

Leica Microsystems, Inc. (Buffalo Grove, IL) initiated this device recall on 4 Sep 2018; FDA lists 1 product record under event 80979, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 17 Aug 2021. Initiation: voluntary: firm initiated. Leica Microsystems, Inc. has 33 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Leica Microsystems, Inc., Buffalo Grove, IL.

Reason for recall

"The firm received complaints that the instrument tipped over when the swing arm was fully extended."

Distribution

"US and Canada"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-3175-2018	Leica M525 F20 Surgical Microscope System	160 units	Class II	Terminated	26 Sep 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

33events on this register for the firm

Other enforcement events for Leica Microsystems, Inc.

Initiated	Product (first record)	Type	Class	Records
21 Nov 2022	Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system	Device	Class II	3
26 Aug 2022	Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063	Device	Class II	4
3 Nov 2021	Leica Microsystems M220 F12 Microscope Systems	Device	Class II	1
30 Jul 2021	BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375	Device	Class II	1
20 May 2020	Leica ARveo and M530 OH6 microscope systems.	Device	Class II	1
18 Nov 2019	BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polyme	Device	Class II	1
3 May 2019	Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including i	Device	Class II	1
2 Jan 2019	Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the vis	Device	Class II	1
17 Sep 2018	BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments	Device	Class II	1
4 Sep 2018	Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microsco	Device	Class II	1

All 33 events for Leica Microsystems, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The firm received complaints that the instrument tipped over when the swing arm was fully extended."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US and Canada"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Aug 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.