PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported July 15, 2020

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).

Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, un…

Recall #
Z-2520-2020
Affected scope
170
Initiated
January 17, 2020
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
View my saved recalls

Kentec Medical, Inc recalled Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and sing… - a moderate-severity action.

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and sing… was recalled by Kentec Medical, Inc in July 15, 2020. Reason: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enter…. Check the official notice for the remedy. Verify recall #Z-2520-2020 with the FDA Devices before acting.

The recall

Kentec Medical, Inc issued this moderate-severity FDA Devices recall-Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enter….

Moderate
severity level
170 units
affected scope
Class II
classification
July 15, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2520-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2520-2020) was formally reported on July 15, 2020, with the manufacturer initiating the action on January 17, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Kentec Medical, Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 170.

The documented reason for this recall is: 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 pati… Distribution data in the federal record shows the product reached: US: CA, IA, and VA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,422 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,256

Where this recall sits in the database

Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

170

Related Recalls

6

0 from same agency

Product description

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).

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2520-2020
Date reported July 15, 2020
Date initiated January 17, 2020
Recalling firm Kentec Medical, Inc
Firm location Irvine, CA
Affected scope 170
Distribution US: CA, IA, and VA

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

170 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2520-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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).. Recalled by Kentec Medical, Inc. Units affected: 170.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2520-2020.
Where was the recalled product distributed?
Distribution: US: CA, IA, and VA.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2520-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →

Browse all Medical Devices recalls →

Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 15, 2020.

  • Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.