M220 F12 000000000010448367Recalls & reported problems
Leica Microsystems (Schweiz) AG · M220 set microscope, stand, footswitch - for Leica surgical operating microscope system: M220 F12 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 3, 2021Class IITerminated
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Z-0412-2022 · Root cause: Process control · Recall details · FDA record ↗
Other MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY devices
- AESCULAP PV010Aesculap AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY3 recalls8 reports
- OPMI® LUMERA® 300 6137Carl Zeiss Suzhou Co., Ltd. · Microscope, Surgical, General & Plastic Surgery1 recall1 report
- M844 F40 / M822 F40 000000000010448142Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- KINEVO® 900 6640Carl Zeiss Meditec AG · Microscope, Surgical, General & Plastic Surgery1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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