RegWardenFDA facility compliance records
Recall

Class II — B Braun Medical Inc

Recalling firmB. BRAUN MEDICAL SAS
Registered facilityB. BRAUN MEDICAL (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
ProductStimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
Quantity1,783,991 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Initiated2024-05-17
Classified2024-06-11
Recall numberZ-2132-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — B Braun Medical Inc (Z-2132-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94637/

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