One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Summary
The FDA issued a Class II for One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. by Intersurgical Inc. Reason: Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue ir.
Details
Source
Device Recall
External ID
Z-2275-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Lot/Code Info: Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Quantity Affected: 2,800 pieces
Reason for Recall
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-20
Company
East Syracuse, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intersurgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersurgical Inc have FDA actions?
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2275-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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