Medline Industries, Inc. DYNJAA11094ARecalls & reported problems

Medline Industries, Inc. · ANESTHESIA CIRCUIT - LF · Class 1

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327683672), received between Oct 8, 2024 and Oct 31, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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

Gas/Air Leak1
Material Integrity Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryOct 31, 2025Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE CUSTOMER, THE CIRCUITS ARE "LEAKING" AND THEY "SUSPECT THAT THE LEAKING COULD BE COMING FROM THE TUBING" OF THE GAS SAMPLING LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441877 ↗
InjuryNov 5, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2024 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A SCHEDULED SURGERY. PER THE FACILITY THE "ANESTHESIOLOGIST COULD NOT GET THE VENTILATOR TO DELIVER THE PRESCRIBED TIDAL VOLUMES".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20608908 ↗
MalfunctionOct 8, 2024
PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) FOR A SCHEDULED SURGERY. ANESTHESIOLOGIST COULD NOT GET THE VENTILATOR TO DELIVER THE PRESCRIBED TIDAL VOLUMES. AFTER MULTIPLE CHECKS ON THE VENTILATOR AND CIRCUIT CONNECTIONS, THE CIRCUIT TUBING WAS CHANGED. THIS INTERVENTION OF CHANGING THE CIRCUIT ALLOWED THE PRESCRIBED VOLUMES TO BE DELIVERED TO THE PATIENT. MEANWHILE, THE ANESTHESIOLOGIST WAS ABLE TO BAG VENTILATE THE PATIENT TO GET DESIRED TIDAL VOLUMES. MANUFACTURER RESPONSE FOR CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE), MEDLINE INDUSTRIES, INC. (PER SITE REPORTER): OTHER DEFECTIVE ANESTHESIA CIRCUITS WERE RETURNED TO THE FIELD REPRESENTATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395473 ↗

Device details

UDI-DI	`10195327683672`
Brand	Medline Industries, Inc.
Model	DYNJAA11094A
Company	Medline Industries, Inc.
Product code	CAI · Circuit, breathing (w connector, adaptor, y piece)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 2024

Device type (GMDN): General surgical procedure kit, non-medicated, single-use

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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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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