Facility

APPLIED MEDICAL TECHNOLOGY, INC.

8 recall(s) on record — most severe on record: Class II.

Key facts

8recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1526012
Establishment type	Manufacture Medical Device
Location	8006 Katherine Blvd Brecksville, OH, US 44141
Registration status	Active · expires 2026
Parent company	APPLIED MEDICAL TECHNOLOGY, INC. (owner-operator 1526012)
Brand names	AMT Introducer (Guidewire Compatible); AMT Introducer

Activity by year

Recalls (8)

Devices registered here (1)

Tubes, Gastrointestinal (And Accessories)
Product code KNT (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980

Recalls & enforcement

Class IICompleted2025-10-06
The nasal feeding tube may be occluded
Class IICompleted2025-08-12
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class IICompleted2024-11-26
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Class IICompleted2024-05-14
Devices were labelled with the incorrect guidewire labelling.
Class IIITerminated2020-11-10
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Class IIITerminated2017-01-19
Expired expiration dates are listed on the pouches.
Class IITerminated2016-02-17
The firm received a complaint of an open pouch which breaches the sterilization validation.
Class IITerminated2016-01-26
The firm received complaints that the product is shorter in length than indicated on the label.

All facilities operated by APPLIED MEDICAL TECHNOLOGY, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “APPLIED MEDICAL TECHNOLOGY, INC. (FEI 1526012) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1526012-applied-medical-technology-inc/

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