Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 55 recalls
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrar…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…