Use caution Medical device recall · FDA · Published June 4, 2018

Leica M320 Microscope Systems Recall: Possible screw failure causing optics carrier drop

Leica Microsystems recalls M320 Microscope Systems with specific article numbers due to risk of screw failure that may cause optics carrier to drop. Affected units include specific serial numbers and article numbers listed in the notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2555-2018Medical device Leica ›

Use caution until it’s fixed

Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

Take action

Contact the company

Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622

✎ GovInfoNow plain-language explainer

Leica Microsystems is recalling M320 Microscope Systems with certain article numbers because screws holding the gas spring bracket could fail. This might cause the microscope's optics carrier to drop, potentially leading to damage or injury if the microscope is used improperly. Read more at govinfonow.com/recall/70909-leica-m320-microscope-systems-recall-possible-screw-failure-causing-optics.

Source Summary by GovInfoNow · govinfonow.com/recall/70909-leica-m320-microscope-systems-recall-possible-screw-failure-causing-optics · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2555-2018

Cite this page

“Leica M320 Microscope Systems Recall: Possible screw failure causing optics carrier drop.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70909-leica-m320-microscope-systems-recall-possible-screw-failure-causing-optics. Based on FDA recall #Z-2555-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2018%22&limit=1).

The FDA announced on June 4, 2018, that Leica Microsystems, Inc. is recalling Leica M320 Microscope Systems due to a possible failure of screws holding the gas spring fixation bracket. This defect prevents the gas spring from supporting the optics carrier's weight. The agency issued recall number Z-2555-2018.

How to tell if you have it

Leica M320 Microscope Systems, Article Number 10448419
Leica M320 Microscope Systems, Article Number 10448420
Leica M320 Microscope Systems, Article Number 10448485
Leica M320 Microscope Systems, Article Number 10448486

The hazard

The screws holding the gas spring fixation bracket in place may fail. Due to this failure, the gas spring fixed to the upper part of the parallelogram cannot hold up the weight of the optics carrier.

Context

GovInfoNow's records show Leica Microsystems, Inc. has had 15 other recalls since June 19, 2017. Recent Leica recalls include a November 21, 2022 notice for Proveo 8 Surgical Microscopes regarding overheating and an August 26, 2022 notice for M530 OHX Surgical Microscopes concerning inaccurate illumination. Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall (August 4, 2026), Canon Alphenix INFX-8000F X-Ray System Recall (December 19, 2025), and GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026).

How to tell if you have this one

Check for Leica M320 Microscope Systems with article numbers 10448419, 10448420, 10448485, or 10448486. The specific serial numbers listed in the recall notice indicate which units are affected.

Brand
Leica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Affected Units
Identify if your microscope has article numbers 10448419, 10448420, 10448485, or 10448486 with the listed serial numbers.
Stop Using if Unsure
If you cannot confirm the article number or serial numbers, stop using the microscope until you verify it is not affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 22 states.

FDA distribution: “Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Jun 4, 2018Firm started the recall
Jul 26, 2018FDA classified it Class II
Aug 1, 2018Published in FDA’s Enforcement Report
Mar 25, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/70909-leica-m320-microscope-systems-recall-possible-screw-failure-causing-optics">Leica M320 Microscope Systems Recall: Possible screw failure causing optics carrier drop (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2555-2018 (June 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2555-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.