FDA Class II Recall: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI… by BD SWITZERLAND SARL

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic (additional items listed in FDA's full record) -- and the recall number Z-2514-2026. If it matches, stop using or distributing it and contact BD SWITZERLAND SARL or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is BD SWITZERLAND SARL and the affected product is described in FDA's record as: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.. The recall is tracked under FDA recall number Z-2514-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

BD SWITZERLAND SARL’s FDA history

Argus HQ has recorded 1 total FDA action tied to BD SWITZERLAND SARL: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has BD SWITZERLAND SARL had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for BD SWITZERLAND SARL so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number Z-2514-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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