MEDLINE RENEWAL D11LTRRecalls & reported problems

Medline Industries, Inc. · D11LT ENDPH XCEL DILATING TIP TROCAR, W · Class 2

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 10080196385591), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

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.

MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923179 ↗

Device details

UDI-DI	`10080196385591`
Brand	MEDLINE RENEWAL
Model	D11LTR
Company	Medline Industries, Inc.
Product code	NLM · Laparoscope, general & plastic surgery, reprocessed
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 17, 2023

Device type (GMDN): Laparoscopic access cannula, reprocessed

A sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall. It is available in a variety of dimensions and/or designs. This is a previously used single-use device that has been processed for an additional single-use patient application.

Other Laparoscope, general & plastic surgery, reprocessed devices

N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall17 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall16 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall3 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall2 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall0 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall0 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
1 recall0 reports
N/A
Stryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
13 reports

All Laparoscope, general & plastic surgery, reprocessed 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.

How reports and recalls are matched · Editorial policy · Report an error on this page