Leica M525 F20 Surgical Microscope System
Medical device recall Z-3175-2018. Published in FDA’s Enforcement Report on Sep 26, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 160 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Leica M525 F20 Surgical Microscope System
160 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 10714001 10813001 11010001 11010002 20312001 20316001 20513001 20518001 20813001 20911002 20916001 30112001 30412001 30616001 30813001 30813002 40112001 40310001 40510001 40610001 40916001 41215001 50218001 50813001…
Every code shown here, 1,702 characters
Serial Numbers: 10714001 10813001 11010001 11010002 20312001 20316001 20513001 20518001 20813001 20911002 20916001 30112001 30412001 30616001 30813001 30813002 40112001 40310001 40510001 40610001 40916001 41215001 50218001 50813001 51011001 51015001 51116001 60218001 60317001 60415001 60813001 70116002 70414001 70714001 71010001 71011001 80114001 80212002 80316001 80513001 80611001 80817001 81014001 90317001 90610001 91117001 91215001 100310001 100317001 100616001 101211001 101216001 110110001 110112001 110116001 110310001 110517001 110809001 110816001 120116001 121216001 130313001 130813001 131010002 131011001 131115001 131211001 131212001 131216001 131216002 140214001 140413001 140612001 140813001 141209001 150415001 150612001 150813001 151013001 151116002 151210001 151211001 151211002 151215001 160216001 160313001 160418001 160810001 160911001 161210002 170310001 170809001 170811001 170916001 170917001 180116001 180117001 180213001 180216001 180511001 180610001 180612001 181111001 190214002 190309001 190316001 190813001 200418001 200910001 210115001 210214001 210316001 211010001 220715001 220909001 220916001 221010002 230909001 230910001 230916001 231109001 231116001 231213001 240712001 240713001 250218001 250414001 250510001 250516001 250814001 250816001 250914001 260514001 260815002 260914001 270810001 280118001 280217001 280411001 280414001 280513001 280910002 280911001 281111001 281113001 290116001 290212001 290515001 290713001 290817001 290817002 290912001 300414001 300418001 300516001 300713001 300816001 310514001 310810001 310815001 The following serial numbers were added in October, 2018. 140415001 170415001 170415002 40714001 170212001 70116001 70513001 90513001
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US and Canada
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 4, 2018.
- FDA classified it on Sep 14, 2018.
- FDA’s Enforcement Report published it on Sep 26, 2018.
- FDA terminated it on Aug 17, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Leica Microsystems, Inc., of Buffalo Grove, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.