Medline Kits containing ENFIT G-TUBE CONNECTOR recallZ-1691-2026 · Medline Industries, LP · initiated Feb 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1691-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 13, 2026
- Posted by the FDA
- Mar 27, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 9,040 kits
- Product code
- PIO
- Distribution
- Worldwide - US Nationwide and the countries of Canada.
Product description
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Code information (models, lots, serial numbers)
1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. ENFITDISCKITMedline Industries, Inc. · General surgery tray1 recall0 reports
- Medline Industries, Inc. DYKM2720Medline Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98524).
- Z-1690-2026 · Open, ClassifiedENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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