POLYURETHANE ENFit — Class II medical device recall Z-3074-2017
Terminated recall by Kentec Medical Inc, reported 2017-09-06, distributed in CA, IL, KS, TX, VA. Inadequate detectability of radiopaque stripes
| Recall number | Z-3074-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kentec Medical Inc, Irvine, CA, United States |
| Recall initiated | 2017-06-23 |
| Classified | 2017-08-25 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2020-04-14 |
| Distributed | CA, IL, KS, TX, VA |
| Lot numbers | KS1606035, KS1606036, KS1606037, KS1606038, KS1608011, KS1608012, KS1608013, KS1608014, KS1608015 |
Product
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.
Reason for recall
Inadequate detectability of radiopaque stripes
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3074-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.