RecallReported September 23, 2026
Class II recall by embecta Medical II LLC
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
FDA's enforcement report of September 23, 2026 lists a Class II recall by embecta Medical II LLC of Parsippany, NJ. Product: EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100. Status: Ongoing.
On the record
- Recalling firm
- embecta Medical II LLC
- Location
- Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3179-2026
- Product type
- Devices
- Recall initiated
- 2023-07-26
- Reported by FDA
- 2026-09-23
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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