Ameritus ENFit ENF-Y80P-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817522012384), received between Jun 29, 2017 and Jun 29, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K100526); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2017Nonstandard Device; Nonstandard Device; Positioning Problem

  INDWELLING FEEDING TUBE WAS NOT VISIBLE UNDER XRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678489 ↗
• MalfunctionJun 29, 2017Nonstandard Device; Material Integrity Problem

  INDWELLING FEEDING TUBE WAS NOT VISIBLE UNDER XRAY.

  Patient problems: No Information

  MAUDE report 6676697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100526. One submission often covers many models, so check the product and lot details in each record.

• Z-2515-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
• Z-2517-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
• Z-2519-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port
• Z-2516-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
• Z-2514-2020 · Jan 17, 2020 · Terminated
  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).
• Z-2518-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port
• Z-2520-2020 · Jan 17, 2020 · Terminated
  Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port
• Z-3073-2017 · Jun 23, 2017 · Terminated
  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) EN
• Z-3074-2017 · Jun 23, 2017 · Terminated
  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