—#215530

Product

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.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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:

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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 recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US distribution to: AL, CA, DE, OR, TN, TX

Timeline

Recall initiated: 2025-07-25
Posted by FDA: 2025-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.