Embecta recalls
3 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Embecta and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-09-23FDA-DeviceClass IIEmbecta Medical II pen needles distributed without investigational label
Embecta Medical II LLC inadvertently distributed 3,000 pen needles labeled 'For Investigational Use Only' as if they were approved commercial devices. These samples were intended only for research and testing, not for patient use. The needles were distributed across 22 U.S. states.
- 2026-09-23FDA-DeviceClass IIEmbecta pen needles distributed without investigational-use restrictions
Embecta Medical II LLC inadvertently distributed 4,300 pen needles labeled 'For Investigational Use Only' as regular commercial products across 22 US states. These devices were meant only for research and testing, not for patient use. No injuries have been reported.
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