Key facts
| Recalling firm | Intersurgical Inc |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. |
| Classification | Class II |
| Recall number | Z-2953-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Devices could potentially be occluded or partially occluded. |
What this classification means
A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Intersurgical Inc. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Intersurgical Inc should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Intersurgical Inc directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
Intersurgical Inc’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Intersurgical Inc: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Is One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oro recalled?
- Yes. FDA lists a Class II recall by Intersurgical Inc for One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device., reported 20260826, with status "Ongoing." FDA recall number: Z-2953-2026.
- What is the recall class for Intersurgical Inc's recall?
- FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
- Why was One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oro recalled?
- FDA's recall record states the reason as: Devices could potentially be occluded or partially occluded.
- Who should I contact about this recall?
- Contact Intersurgical Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
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Related enforcement actions
Full FDA history for Intersurgical IncCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: One-Piece Guedel Airway, size 000, ISO 3.5, Light… by Intersurgical Inc. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/intersurgical-z-2953-2026-2026-08-26
"FDA Recall Database: Class II Recall: One-Piece Guedel Airway, size 000, ISO 3.5, Light… by Intersurgical Inc." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/intersurgical-z-2953-2026-2026-08-26.
Argus HQ Research. "FDA Recall Database: Class II Recall: One-Piece Guedel Airway, size 000, ISO 3.5, Light… by Intersurgical Inc." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/recall/intersurgical-z-2953-2026-2026-08-26.
@misc{argushq_argushq_ai_recall_intersurgical_z_2953_2026_2026_08_26_2026,
title = {FDA Recall Database: Class II Recall: One-Piece Guedel Airway, size 000, ISO 3.5, Light… by Intersurgical Inc},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/intersurgical-z-2953-2026-2026-08-26},
note = {Accessed: September 8, 2026}
}Source: FDA.gov — Recalls ↗