CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Leica M525 F20 Surgical Microscope System recalled by Leica Microsystems
Leica Microsystems is recalling Leica M525 F20 Surgical Microscope System. The recall was initiated on 4 Sep 2018 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-3175-2018
- FDA event ID
- 80979
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 14 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 14 Sep 2018 | Classified by FDA | +10 days |
| 26 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
Product as listed by the FDA
Leica M525 F20 Surgical Microscope System
Where it was distributed
US and Canada
Questions about this recall
Why was it recalled?
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
Which lots are affected?
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
Where was it sold?
US and Canada
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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