🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Fujifilm is conducting a corrective action due to an FDA inspection.
🏥 Medical Devices Class I - Dangerous
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
🏥 Medical Devices Class I - Dangerous
Software discrepancy of not showing all the EE constants, when the screen is filled.
🏥 Medical Devices Class I - Dangerous
Presence of loose polypropylene foreign matter above release specification.
🏥 Medical Devices Class I - Dangerous
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
🏥 Medical Devices Class I - Dangerous
Software discrepancy of not showing all the EE constants, when the screen is filled.
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Leonhard Lang Medizintechnik GmbH
🏥 Medical Devices Class I - Dangerous
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
🏥 Medical Devices Class I - Dangerous
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
🏥 Medical Devices Class I - Dangerous
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
🏥 Medical Devices Class I - Dangerous
Some anomalies have been identified during manufacturing controls.
🏥 Medical Devices Class I - Dangerous
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
🏥 Medical Devices Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.