CLASS I ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
Medline medical convenience kits labeled as recalled
Medline Industries LP - Northfield is recalling Medline medical convenience kits labeled as: Newborn Resuscitation Kit, Kit Number, distributed in Alabama, California, Delaware, Oregon, Tennessee, Texas. The recall was initiated on 25 Jul 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2567-2025
- FDA event ID
- 97411
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 25 Jul 2025
- FDA classified
- 19 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Jul 2025 | Recall initiated by company | |
| 19 Sep 2025 | Classified by FDA | +56 days |
| 1 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US distribution to: AL, CA, DE, OR, TN, TX
Questions about this recall
Why was it 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.
Which lots are affected?
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:
Where was it sold?
US distribution to: AL, CA, DE, OR, TN, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97411This product is part of a recall event; the main page for the event is Medline medical convenience kits labeled as recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
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