Complete FDA and NHTSA recall records dated in 2021, 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.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
Marketed without a 510K
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Marketed without a 510K
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
The pump has an impeller with a shroud height that did not meet the lower control limit.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
Label declares lecithin but does not declare soy lecithin.
Potential undeclared peanut allergen.
Label declares lecithin but does not declare soy lecithin.
Label declares lecithin but does not declare soy lecithin.
Label declares lecithin but does not declare soy lecithin.
Label declares lecithin but does not declare soy lecithin.
Label declares lecithin but does not declare soy lecithin.
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established…
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.
