MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1403-2020
The devices may be missing the implant coil.
Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The devices may be missing the implant coil.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to…
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
The devices may be missing the implant coil.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
The devices may be missing the implant coil.
Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
FDA testing found almond protein in the products, which is not an ingredient in the product.
Possible foreign material.
Possible foreign material.
Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
Possible foreign material.
Possible foreign material.
Firm was notified that their Gluten Free Soup mix labeling is misleading as pasta containing wheat is an ingredient.
Possible foreign material.
FDA testing found almond protein in the products, which is not an ingredient in the product.
Possible foreign material.
Possible foreign material.
Pad Thai Noodle Bowl which contains peanuts was packaged with the sleeve for Teriyaki Noodle Bowl leaving undeclared peanuts on the product label.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.