Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue
B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving labeling inaccuracy where the product claims to be DEHP-free but contains DEHP traces. While no illnesses or injuries have been reported, this constitutes a risk-of-harm situation for healthcare providers and patients who select these devices specifically to avoid DEHP exposure.
Plain-English summary
B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles. The devices are labeled as 'not made with DEHP' or bear a DEHP-free symbol, but the glue component contains traces of DEHP, creating a discrepancy between the product labeling and actual composition.
These needles (30 degree angle, 20 gauge, 6 inch length) were distributed nationwide in the United States and in Canada. The recall affects multiple lot numbers produced between 2019 and 2023.
Healthcare providers who have used or stocked these devices should verify lot numbers against the recalled batch list and contact B Braun Medical Inc regarding device replacement and proper disposition.
The recalled product
- Product
- Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
- Manufacturer
- B Braun Medical Inc
- Affected units
- 108,811
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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