Olympus Recalls Celon ProBreath and Celon ProSleep Applicators Due to Missing Instructions

Source: Health Canada · Canada

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Olympus has issued a recall for specific lots of Celon ProBreath and Celon ProSleep Plus bipolar applicators because they were distributed without the required Instructions for Use (IFU).

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on February 22, 2026 and geographically references Canada. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Olympus has identified that certain boxes of Celon ProBreath and Celon ProSleep Plus bipolar applicators were released to customers without the required Instructions For Use (IFU) included. This documentation is necessary for the proper operation and handling of the medical devices.

Which Products Are Affected

The recall involves the following products manufactured by Olympus Winter & Ibe Gmbh:

  • Celon ProSleep Plus Bipolar Applicator: Model WB990008, Lot/Serial 1000169653
  • Celon ProSleep Plus: Model WB990095, Lot/Serial 1000169656
  • Celon ProBreath Bipolar Applicator: Model WB990007, Lots/Serials 1000172949, 1000172947, 1000171773, 1000172948, and 1000169475

What You Should Do

Users who have purchased these products should immediately contact the Olympus Canada Technical Assistance Center (TAC) to obtain the missing Instructions For Use. Once the IFU is received, users must ensure a copy is placed with the device for reference by medical staff.

Why This Matters

Instructions for Use are critical for ensuring that medical devices are used safely and according to the manufacturer's specifications. The absence of these instructions could lead to improper use of the bipolar applicators.

Source

For more information, visit the official Health Canada recall notice.

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Olympus has issued a recall for specific lots of Celon ProBreath and Celon ProSleep Plus bipolar applicators because they were distributed without the required Instructions for Use (IFU).
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.