Ameritus Medical Products ENFit Polyurethane and Silicone Feeding… — Class II medical device recall Z-2514-2020
Terminated recall by Kentec Medical, Inc, reported 2020-07-15, distributed in CA, IA, VA. Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral
| Recall number | Z-2514-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kentec Medical, Inc, Irvine, CA, United States |
| Recall initiated | 2020-01-17 |
| Classified | 2020-07-06 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-10-21 |
| Distributed | CA, IA, VA |
| Quantity | 480 |
| Reason classes | device malfunction |
| Lot numbers | KS1711017 |
| Model numbers | ENF-40P-50 |
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
Reason for recall
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
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-2514-2020. 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.