Z-1691-2026Class II

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT...

Name: Z-1691-2026 Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT...
Creator: Medline Industries, LP
Published: 2026-02-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-13 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT on 2026-02-13. FDA classified it as Class II and gives the reason as "Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1691-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-13
Posted: 2026-03-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Product code: PIO Enteral Specific Transition Connectors
Reason for recall: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On February 13, 2026, the firm notified affected consignees via Urgent Medical Device Recall letters delivered through First Class mail and email. Customers were instructed to destroy all affected ENFit G-Tube connectors and kits that contain the G-Tube connectors.
Quantity in commerce: 9,040 kits
Distribution: Worldwide - US Nationwide and the countries of Canada.
Product codes and lots: 1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1691-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code PIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)