Complete FDA and NHTSA recall records dated in 2018, 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.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is…
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for…
Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed…
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure…
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft…
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft…
The suction valve may not close properly which could cause continuous suction.
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is…
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft…
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is…
If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to…
It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend…
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
The suction valve may not close properly which could cause continuous suction.
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.
