This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Products
This recall contains Medline medical convenience kits containing the Flexicare BritePro Solo, including convenience kits labeled as:
| Device Name | Kit Number | UDI-DI | Lots |
|---|---|---|---|
| NEWBORN RESUSCITATION KIT | ACC010381C | 10193489922127 (EA), 40193489922128 (CS) | 21LDA450, 21KDA979, 21JDB271, 21LDA608 |
| DRAWER 5 - POSITION 3 | ACC010532 | 10193489902358 (EA), 40193489902359 (CS) | 21FDA234 |
| DRAWER #4C ADULT | ACC010671 | 10195327351090 (EA), 40195327351091 (CS) | 23EDC536 |
| DRAWER #2 | ACC010728 | UDI/DI 10195327506544 (EA), 40195327506545 (CS) | 24EDC276, 23KDC368, 23KDB032 |
| ADULT INTUBATION TRAY | ACC010369B | 10193489777512 (EA) 40193489777513(CA) | 21DDA738, 21CDA614, 21BDA717 |
| ADULT ICU INTUBATION TRAY | ACC010379A | 10193489777529 (EA) 40193489777520(CA) | 21BDB738, 21BDB493 |
| INTUBATION TRAY | ACC010392 | 10193489218053 (EA) 40193489218054(CA) | 24JDA206, 21HDB930, 21HDA284, 21EDB901, 21EDB869, 21EDB805 |
| INTUBATION KIT | ACC010467A | 10193489834550 (EA) 40193489834551(CA) | 21EDA887 |
| ADULT AIRWAY TRAY | ACC010469 | 10193489414677 (EA) 40193489414678(CA) | 22BDA430, 21KDA741, 21CDA522, 21BDA753 |
| TRAY 2 INTUBATION DRAWER | ACC010480 | 10193489499933 (EA) 40193489499934(CA) | 21HDA876, 21FDB951, 21FDB019, 21EDA065, 21CDB872, 21BDB094 |
| TRAY 2 INTUBATION DRAWER | ACC010480A | 10195327009366 (EA) 40195327009367(CA) | 21JDB163 |
| ADULT INTUBATION | ACC010540 | 10193489977547 (EA) 40193489977548(CA) | 21IDC276 |
| DIFFICULT AIRWAY TRAY #1 | ACC010593A | 10195327168995 (EA) 40195327168996(CA) | 22EDB290 |
| DIFFICULT AIRWAY TRAY #1 | ACC010593B | 10195327195472 (EA) 40195327195473(CA) | 22FDB947 |
| INTUBATION TRAY | DYNDA1847A | 10193489481259 (EA) 40193489481250(CA) | 21FBG208, 21CBL507 |
| INTUBATION TRAY (ADULT) | DYNJAA245A | 10193489804584 (EA) 40193489804585(CA) | 21LBV006, 21IBV349, 21HBT154, 21DBI703, 21CBN261 |
What to Do
Place the over-labels provided by Medline Industries on affected kits to indicate that the affected component should be removed and discarded prior to using the kit.
On July 25, 2025, Medline Industries, LP sent all affected customers an immediate action required medical device recall recommending the following actions:
- 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.
- Please complete the recall response form. Please list the quantity of affected product in inventory on the form. Even if there is no affected product in inventory, please complete and submit the form.
- Upon receipt of the submitted response form, over-labels will be provided to be placed on affected inventory, with instructions for staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
- Alert any person or company to whom this kit may have been resold or transferred of this recall communication. Please include customers’ quantities on the response form. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Updated Use Instructions
Medline Industries, LP is updating the use instructions for their medical convenience kits containing the previously recalled component Flexicare BritePro Solo due to the light not illuminating as intended. If the light malfunctions, it may prevent effective illumination of the patient airway.
The use of affected product may cause serious adverse health consequences, including delay in treatment or requiring intubation using a different device and possibly death.
As of August 8, 2005, Medline Industries has not reported any serious injuries or deaths associated with this issue.
Device Use
This recall is for Medline medical convenience kits containing the Flexicare BritePro Solo. The BritePro Solo devices are intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by inserting the laryngoscope blade into the oral cavity to manipulate the tongue or epiglottis.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact the Medline Recall Department at 866-359-1704 or recalls@medline.com.
Additional FDA Resources:
Additional Company Resources:
Company provided information on a recall, is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
