PV Bulletin

Urgent Field Safety Notice (RECALL) - One-Piece Guedel Airways

Swissmedic issued an Urgent Field Safety Notice for One-Piece Guedel Airways (sizes 00 and 000) by Intersurgical due to occluded or partially occluded tips, which may cause respiratory distress, hypoxia, or neurological impairment. Affected lots have expiry dates from 2026-06 to 2031-02.

Primary source: Swissmedic

PV Impact Brief

Urgency: HighConfidence: high

What changed

Swissmedic published an Urgent Field Safety Notice (Recall) for One-Piece Guedel Airways due to the safety issue of occluded tips.

Why it matters

Use of affected devices may lead to respiratory distress, hypoxia, or neurological impairment when establishing a patent airway.

Action needed

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Regulatory action details

Action type
Field Safety Notice / Recall
Publication date
2026-06-05
Safety issue
Some devices were found with occluded or partially occluded tips, which may lead to respiratory distress, hypoxia, or neurological impairment if used for establishing a patent airway.

Affected products

  • One-Piece Guedel Airways (size 00 and size 000)
    Intersurgical
    All lots with expiry 2026-06 to 2031-02

PV internal implications

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 5, 2026

Full briefing

Practical implication

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Swissmedic issued a Field Safety Notice for One-Piece Guedel Airways (Intersurgical, sizes 00 and 000) due to occluded tips. Required actions: identify, quarantine, return/destroy affected products, and complete reply form. Affected models: 1100050, 1100050S, 8100050, 1000035, 1000035S, 8000035; lots with expiry 2026-06 to 2031-02.

What changed: Swissmedic published an Urgent Field Safety Notice (Recall) for One-Piece Guedel Airways due to the safety issue of occluded tips.

Why it matters: Use of affected devices may lead to respiratory distress, hypoxia, or neurological impairment when establishing a patent airway.

Practical implication: Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#Field Safety Notice / Recall#Swissmedic#safety_signal#firecrawl-agent#regulatory-extraction

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