Class II U.S. Food and Drug Administration

Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0 recall: Devices could potentially be occluded or partially occluded

Recall published 2 months ago

Devices could potentially be occluded or partially occluded.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Devices could potentially be occluded or partially occluded.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2952-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Intersurgical Inc
Product type
Medical devices
Units affected
21,269 units
Distribution
Nationwide
Made in
United States
Lot / code info
REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.
UPC codes
5030267050185, 05030267044450

Products covered by this recall

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 5030267050185
  • 05030267044450

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 32121232
  • 32208193
  • 32400267
  • 32403734
  • 32408819
  • 32409672
  • 32416545

Model or item number

On the rating label, the box or the instruction sheet.

  • 1100050

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Intersurgical Inc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Intersurgical Inc — 5010 Campuswood Dr Ste 102, East Syracuse, NY, 13057-1561

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Intersurgical Inc medical devices recalled?

Devices could potentially be occluded or partially occluded. Devices could potentially be occluded or partially occluded.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 5030267050185, 05030267044450; lot code 32121232, 32208193, 32400267; model number 1100050. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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