Grip-Lok 3400LRecalls & reported problems

Tidi Products, LLC · Large Securement Device, For lines and tubes sized 16-40 Fr · Class 2

All models of Grip-Lok (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618125134755), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loss of or Failure to Bond1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
CUSTOMER REPORTED VIA HUBSPOT: I ORDERED A BOX OF GRIP LOKS SZ LARGE ONLINE THEY ARE NOT STICKING THEY FALL OFF OVERNIGHT. I REALLY NEEDED THESE TO KEEP MY TUBE IN PLACE WHILE I WAIT ON SURGERY. CAN YOU HELP ME THESE ARE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082841 ↗

Device details

UDI-DI	`00618125134755`
Brand	Grip-Lok
Model	3400L
Company	Tidi Products, LLC
Product code	PLI · Gastrointestional Tube Holder
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 23, 2026

Device type (GMDN): Nasogastric tube holder, noninvasive

A small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device.

Other Gastrointestional Tube Holder devices

Grip-Lok 3200S
Tidi Products, LLC · Gastrointestional Tube Holder
2 reports

All Gastrointestional Tube Holder devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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