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Dynj909119g Robotic Gastric Lap Sleeve-Lf recallZ-0446-2026 · Medline Industries, LP · initiated Oct 10, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Safety notice was provided to customers on 10/10/2025. Follow-up "URGENT MEDICAL DEVICE RECALL" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail. Customers were instructed to Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product and destroy affected kits on hand. No products are to be returned to Medline. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-215-FG Recall Code: If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. An expanded "URGENT MEDICAL DEVICE RECALL" notification dated 10/24/2025 was provided to customers on 10/24/25, which included additional affected products. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0446-2026
Status
Open, Classified
Initiated by the company
Oct 10, 2025
Posted by the FDA
Nov 13, 2025
Recalling firm
Medline Industries, LP
Quantity
96,406 total units
Product code
FDE
Distribution
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

Product description

DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

Code information (models, lots, serial numbers)

CYSTO DYNJ909127F UDI-DI 40198459055424 (case), 10198459055423 (ea) Lots 25FBP819 25GBM605; GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case), 10198459055263 (ea) Lots 25FBV537; ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case), 10198459130526 (ea) Lots 25FBP681

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97882).

Sources and updates

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