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.
GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation…
Potential hardware issue which may cause thermal effects and possible damage to system parts.
An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have…
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated…
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated…
Mix-up between adult and pediatrics PD catheter.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation…
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.
