SteriPath Gen2, 21G, BD 27BD-21-ENRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K192247); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 2, 2021Class IITerminated

   Due to an uptick of complaints associated with premature needle retraction of blood collection system.

   Z-0318-2022 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192247. One submission often covers many models, so check the product and lot details in each record.

• Z-2393-2021 · Aug 2, 2021 · Terminated
  Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Colle