FDAClass II · Medical device · Recall Z-2953-2026 · Recalled August 26, 2026

One-Piece Guedel Airway recall — Intersurgical Inc

Agency report date: August 26, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: One-Piece Guedel Airway
Company / brand: Intersurgical
Lot / serial / date codes: REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.

Agency product description and boundaries

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Devices could potentially be occluded or partially occluded.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: One-Piece Guedel Airway recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2953-2026
Brand: All Intersurgical recalls
Classification: Class II
Units affected: 1,575 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

One-Piece Guedel Airway recall status

Companies & origin

Recalling firm location: East Syracuse, NY, United States
Firm address: 5010 Campuswood Dr Ste 102, 13057-1561

Identifying details (verbatim from the notice)

Product codes / lots: REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Firm notified the public via: E-Mail
FDA event ID: 99284
Recall initiated: June 15, 2026
FDA classified: August 14, 2026
FDA report date: August 26, 2026

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Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall — Boston Scientific CorporationFDA · August 26, 2026
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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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