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

Leica HistoCore SPECTRA CV Coverslipper Recall: Improper Electrical Shielding Risk

Leica recalls HistoCore SPECT: Improper electrical shielding due to wrong fiberglass hose position may cause shock. Affected units have serial number 102.

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

🇺🇸 FDA recall #Z-0019-2019Medical device Leica ›

Use caution until it’s fixed

Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Leica is recalling its HistoCore SPECTRA CV Coverslipper due to improper electrical shielding that could cause shock. This affects lab equipment used in medical tissue analysis. Read more at govinfonow.com/recall/69916-leica-histocore-spectra-cv-coverslipper-recall-improper-electrical-shielding-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69916-leica-histocore-spectra-cv-coverslipper-recall-improper-electrical-shielding-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0019-2019

Cite this page

“Leica HistoCore SPECTRA CV Coverslipper Recall: Improper Electrical Shielding Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69916-leica-histocore-spectra-cv-coverslipper-recall-improper-electrical-shielding-risk. Based on FDA recall #Z-0019-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0019-2019%22&limit=1).

The FDA announced on 2018-09-04 that Leica Microsystems, Inc. is recalling one Leica HistoCore SPECTRA CV Coverslipper due to an improper fiberglass hose assembly that creates a potential electrical shock hazard. The recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Leica
Product: Leica HistoCore SPECTRA CV Coverslipper
Serial Number: 102
Quantity: 1 unit

The hazard

The product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

Context

GovInfoNow's records show Leica Microsystems, Inc. has 15 other recalls on record since 2017-06-19. Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (2025-10-30), Medtronic GUNDRY Cannula Recall (2026-04-21), and GE Allia Moveo X-ray System Recall (2026-04-20).

How to tell if you have this one

Check for the serial number 102 on the coverslipper. This model is used in medical labs for preparing tissue samples for microscopic analysis.

Brand
Leica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Serial Number
Look for the serial number 102 on the coverslipper to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in Missouri.

FDA distribution: “Distribution in US state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Sep 4, 2018Firm started the recall
Oct 3, 2018FDA classified it Class II
Oct 10, 2018Published in FDA’s Enforcement Report
Jul 10, 2020FDA terminated the recall

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

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Keep exploring

More Leica recalls

Link to this recall

<a href="https://govinfonow.com/recall/69916-leica-histocore-spectra-cv-coverslipper-recall-improper-electrical-shielding-risk">Leica HistoCore SPECTRA CV Coverslipper Recall: Improper Electrical Shielding Risk (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-0019-2019 (September 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0019-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.