Medical device nerve block needles incorrectly labeled as DEHP-free
Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error—the product is labeled as DEHP-free but contains trace DEHP in the adhesive. No illnesses or injuries have been reported in connection with this recall. Per the rubric, minor labeling errors without reported adverse events are classified as Moderate.
Plain-English summary
The Stimuplex A nerve block needle (30-degree angle, 21-gauge, 4 inches) is a medical device used for local anesthesia and nerve blocks. These devices are being recalled because they are labeled as "not made with DEHP" or bear a DEHP-free symbol, but the adhesive used in their construction contains trace amounts of DEHP (diethyl phthalate).
The affected devices were distributed worldwide, including throughout the US and Canada. Approximately 1.78 million units are involved in this recall, identified by catalogue number 4894260 and spanning multiple production lots and batches.
Healthcare providers and institutions using these devices should verify the lot and batch numbers against the FDA's recall notice to determine if their supplies are affected. Patients who have received injections with affected devices should consult their healthcare provider with any concerns.
The recalled product
- Product
- Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
- Manufacturer
- B Braun Medical Inc
- Affected units
- 1,783,991
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: 4894260
- UDI/DI: 04022495101211
- Lot/Batch: 22E07
- 20E08
- 20E09
- 23E09
- 23E10
- 19E11
- 23E11
- 23E13
- 19E14
- 20E14
- 19E15
- 19E16
- 23E17
- 23E18
- 23E20
- 22E21
- 21E25
- 22E25
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.
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