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Medline medical convenience kits labeled as recallZ-2567-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jul 25, 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 - Northfield 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

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.

FDA root cause category: Component design/selection

What the company is doing

Medline Industries issued a MEDICAL DEVICE RECALL notice to it consignees on 07/25/2025 via email and USPS first class mail. The notice explained the issue with the component within the kit, potential risk to the patient, and requested the following: REQUIRED ACTION: 1.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. 2.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 form. Website link: https://recalls.medline.comRecall Reference #: R-25-158-FGX1 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4.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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-2567-2025
Status
Open, Classified
Initiated by the company
Jul 25, 2025
Posted by the FDA
Sep 19, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
596 units
Product code
LRO
Distribution
US distribution to: AL, CA, DE, OR, TN, TX

Product description

Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.

Code information (models, lots, serial numbers)

1. ACC010381C: UDI/DI 10193489922127 (EA), 40193489922128 (CS), Kit Lot Numbers: 2. ACC010532: UDI/DI 10193489902358 (EA), 40193489902359 (CS), Kit Lot Numbers: 3. ACC010671: UDI/DI 10195327351090 (EA), 40195327351091 (CS), Kit Lot Numbers: 4. ACC010728: UDI/DI 10195327506544 (EA), 40195327506545 (CS), Kit Lot Numbers:

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 97411).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page