CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Medline Umbilical Tray W/3.5& Cath recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Medline Umbilical Tray W/3.5& Cath, distributed nationwide in the US. The recall was initiated on 15 May 2025 and the FDA has classified it as Class II.
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-1995-2025
- FDA event ID
- 96959
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 15 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +36 days |
| 2 Jul 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
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Where it was distributed
US Nationwide distribution in the state of VA.
Questions about this recall
Why was it recalled?
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Which lots are affected?
UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012
Where was it sold?
US Nationwide distribution in the state of VA.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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