Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content
B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.
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 recall involving mislabeling of a medical device—the product is labeled as DEHP-free but contains traces of DEHP. While no adverse health events have been reported, the false labeling represents a risk-of-harm situation where users who specifically selected the product to avoid DEHP exposure may have been exposed unintentionally.
Plain-English summary
B Braun Medical Inc is recalling 1,157,640 Stimuplex A 30 DEG peripheral nerve block needles (Catalogue Number 4894502) because the devices are labeled "not made with DEHP" or marked with a DEHP-free symbol, but the adhesive contains traces of DEHP.
DEHP is a chemical that some healthcare providers and patients seek to avoid in medical devices. The false labeling means users may have selected this product believing it to be DEHP-free when it actually contains traces of DEHP. The FDA classified this as a Class II recall due to the misrepresentation of the product's composition.
The recalled devices were distributed worldwide, including throughout the United States and Canada. Affected lot numbers span from 2019 to 2023 and are identified in the FDA recall notice.
Users who have Stimuplex A needles with the affected lot numbers should discontinue use and consult their healthcare provider if concerned about DEHP exposure.
The recalled product
- Product
- Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device
- Affected units
- 1,157,640
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: 4894502
- UDI/DI: 04022495101310
- Lot/Batch: 20E01
- 20E03
- 21E07
- 21E09
- 19E10
- 22E10
- 22E11
- 21E13
- 20E19
- 20E20
- 19E21
- 19E22
- 20E22
- 23E26
- 20E27
- 23E31
- 19F12
- 19F13
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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Same hazard · dehp contamination
See all →- HighStimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue
FDA (Devices) · 2024-06-19
- HighBD Extension Sets Mislabeled as DEHP-Free Despite Containing Phthalates
FDA (Devices) · 2023-11-29
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