CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm recalled by B Braun Medical

B Braun Medical is recalling Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, distributed nationwide in the US. The recall was initiated on 17 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue Number: 4894278; UDI/DI: 04022495101266; Lot/Batch: 20E15, 21E18, 19F08, 19G10, 19G13, 19G19, 19I19, 20C28, 20C31, 20D10, 20L19, 21B13, 21I17, 21K21, 21L12, 21M16, 22D12, 22H20, 22I22, 22K27, 23A20, 23C04, 23D14, 23F09, 23I08, 23I29,

Quantity recalled108,811 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-2133-2024
FDA event ID: 94637
Recalling firm: B Braun Medical, Breinigsville, PA
Classification: Class II
Status: Ongoing
Recall initiated: 17 May 2024
FDA classified: 11 Jun 2024
Reported: 19 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 May 2024	Recall initiated by company
11 Jun 2024	Classified by FDA	+25 days
19 Jun 2024	Published in enforcement report	+8 days

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

Reason for recall

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Product as listed by the FDA

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Which lots are affected?

Catalogue Number: 4894278; UDI/DI: 04022495101266; Lot/Batch: 20E15, 21E18, 19F08, 19G10, 19G13, 19G19, 19I19, 20C28, 20C31, 20D10, 20L19, 21B13, 21I17, 21K21, 21L12, 21M16, 22D12, 22H20, 22I22, 22K27, 23A20, 23C04, 23D14, 23F09, 23I08, 23I29,

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

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

3 other products · FDA event 94637

This product is part of a recall event; the main page for the event is Stimuplex A, 30 DEG, 24GX1", 0.55x25mm recalled by B Braun Medical.

Reported	Class	Recall	Company	Reason	Where
19 Jun 2024	CLASS II	Stimuplex A, 30 DEG, 24GX1", 0.55x25mm recalled by B Braun Medical	B Braun Medical	Other	Nationwide
19 Jun 2024	CLASS II	Stimuplex A, 30 DEG, 21GX4", 0.80x100mm recalled by B Braun Medical	B Braun Medical	Other	Nationwide
19 Jun 2024	CLASS II	Stimuplex A, 30 DEG, 22GX2", 0.70x50mm recalled by B Braun Medical	B Braun Medical	Other	Nationwide

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