CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

IV Administration Set utilized recalled by B Braun Medical

B Braun Medical is recalling IV Administration Set utilized in gravity IV administration sets and pump administration, distributed nationwide in the US. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Catalog Number: 490451; Primary UDI-DI: 04046964848919; Unit of Dose UDI-DI: 04046964848902; Expiration Date: Earliest Exp of Comp or 36mths.

Quantity recalled2,544 units

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-0694-2026
FDA event ID: 97816
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Oct 2025
FDA classified: 26 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

29 Oct 2025	Recall initiated by company
26 Nov 2025	Classified by FDA	+28 days
3 Dec 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Product as listed by the FDA

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.; Catalog Number: 490451.

Where it was distributed

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Nationwide

Questions about this recall

Is IV Administration Set utilized in gravity IV administration sets and pump administration recalled?

Yes. B Braun Medical recalled IV Administration Set utilized in gravity IV administration sets and pump administration on 29 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0694-2026.

Why was it recalled?

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Which lots are affected?

1. Catalog Number: 490451; Primary UDI-DI: 04046964848919; Unit of Dose UDI-DI: 04046964848902; Expiration Date: Earliest Exp of Comp or 36mths.

Where was it sold?

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

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 21 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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