CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report

Cesk Shands Jacksonville recalled by B Braun Medical

B Braun Medical is recalling B. Braun Medical Inc Cesk Shands Jacksonville 20055717, distributed nationwide in the US. The recall was initiated on 29 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Model No 555884, UDI-DI (Primary Device) 04046964317361, UDI-DI (Unit Device ID) 04046964317347, Lot Number 0062036271
Quantity recalled680

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-2269-2026
FDA event ID
98862
Recalling firm
B Braun Medical, Bethlehem, PA
Classification
Class II
Status
Ongoing
Recall initiated
29 Jan 2026
FDA classified
29 May 2026
Reported
10 Jun 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction
Device type
Medical Software

Timeline

29 Jan 2026Recall initiated by company
29 May 2026Classified by FDA+120 days
10 Jun 2026Published 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

B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

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

Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No

Where it was distributed

US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

Nationwide AlabamaFloridaPennsylvaniaTexasVirginiaWashington

Questions about this recall

Is Cesk Shands Jacksonville 20055717 recalled?

Yes. B Braun Medical recalled Cesk Shands Jacksonville 20055717 on 29 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-2269-2026.

Why was it recalled?

B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

Which lots are affected?

Lot Code: Model No 555884, UDI-DI (Primary Device) 04046964317361, UDI-DI (Unit Device ID) 04046964317347, Lot Number 0062036271

Where was it sold?

US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

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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