Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE Recalled by Kentec Medical Inc Due to Inadequate detectability of radiopaque stripes

Date: June 23, 2017
Company: Kentec Medical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kentec Medical Inc directly.

Affected Products

POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

Quantity: K100526

Why Was This Recalled?

Inadequate detectability of radiopaque stripes

Where Was This Sold?

This product was distributed to 5 states: CA, IL, KS, TX, VA

Affected (5 states)Not affected

About Kentec Medical Inc

Kentec Medical Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report