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Class IOngoingZ-2567-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Oct 1, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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.

Lot / code information

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

What the firm 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 recalls@medline.com.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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