CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
Medline Kits containing B. Braun IV Administration Sets recalled
Medline Industries is recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, distributed nationwide in the US. The recall was initiated on 26 Nov 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-1053-2026
- FDA event ID
- 98154
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Nov 2025
- FDA classified
- 12 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 26 Nov 2025 | Recall initiated by company | |
| 12 Jan 2026 | Classified by FDA | +47 days |
| 21 Jan 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Product as listed by the FDA
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Which lots are affected?
UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.
Where was it sold?
US Nationwide distribution.
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.
Other products in this recall event
11 other products · FDA event 98154This product is part of a recall event; the main page for the event is Medline Kits containing B. Braun IV Administration Sets recalled.
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