Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 86 recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity.…
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Potential for undetected, deformed a-traumatic tips.