Kentec Medical Recalls ENFit Feeding Tubes Due to Inadequate Radiopaque Stripes
Kentec Medical recalls pediatric ENFit feeding tubes with inadequate radiopaque stripes for X-ray detection. This may cause misdiagnosis during medical imaging. Affected tubes have specific reference numbers and lot numbers listed.
Lower-risk recall
Inadequate detectability of radiopaque stripes
Contact the company
What happened, in plain English
Kentec Medical is recalling certain pediatric feeding tubes because they have radiopaque stripes that are not detectable on X-rays. This could lead to misdiagnosis if the tubes are accidentally used during medical imaging without proper identification. Read more at govinfonow.com/recall/73595-kentec-medical-recalls-enfit-feeding-tubes-due-to-inadequate-radiopaque.
Source Summary by GovInfoNow · govinfonow.com/recall/73595-kentec-medical-recalls-enfit-feeding-tubes-due-to-inadequate-radiopaque · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3073-2017
Cite this page
“Kentec Medical Recalls ENFit Feeding Tubes Due to Inadequate Radiopaque Stripes.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73595-kentec-medical-recalls-enfit-feeding-tubes-due-to-inadequate-radiopaque. Based on FDA recall #Z-3073-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3073-2017%22&limit=1).
Why it’s dangerous
The radiopaque stripes on these feeding tubes are not clearly visible on X-rays, which could cause misdiagnosis if the tubes are accidentally placed in a patient's body during medical imaging. This is a risk during procedures where X-rays are used to locate the tube.
Who’s affected
Patients using pediatric or neonatal feeding tubes with the specific reference numbers and lot numbers listed. Healthcare providers and caregivers who handle these tubes are most at risk.
How to tell if you have this one
Check the reference numbers on the tube: ENF-50P-40, ENF-50P-50, ENF-50P-80, ENF-60P-40, ENF-60P-50, ENF-60P-80, ENF-80P-40, ENF-80P-50, ENF-80P-80, or ENF-100P-110. Also check the lot numbers listed for each reference number.
- Brand
Kentec Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
TX, VA, IL, CA, KS
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3073-2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.; a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010 | 54 boxes of 10 individual units |
| Z-3074-2017 | 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.; a) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038 | K100526 |
What to do — step by step
Check Tube Reference Numbers
Look for reference numbers on the tube: ENF-50P-40, ENF-50P-50, ENF-50P-80, ENF-60P-40, ENF-60P-50, ENF-60P-80, ENF-80P-40, ENF-80P-50, ENF-80P-80, or ENF-100P-110.
Verify Lot Numbers
Check the lot numbers for each reference number: KS1606031, KS1606028, KS1608007, KS1608008, KS1606029, KS1608009, KS1606032, KS1606030, KS1606034, or KS1608010.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “TX, VA, IL, CA, KS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Kansas, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3073-2017 (June 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3073-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.