embecta Medical II LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to EMBC.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100Class IIJul 26, 2023Retrospectively reported: Pen needles labeled 'For Investiga	Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as	Class IIDevices	Jul 26, 2023
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100Class IIJul 26, 2023Retrospectively reported: Pen needles labeled 'For Investiga	Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as	Class IIDevices	Jul 26, 2023