Complete FDA and NHTSA recall records dated in October 2021.
These records include useful source details for the selected month.
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Customers were not notified of previous recalls associated with various defibrillator models.
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Customers were not notified of previous recalls associated with various defibrillator models.
Missing splash guard which may expose users to hazardous materials. .
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
There is a potential for false positive results.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may…
Customers were not notified of previous recalls associated with various defibrillator models.
There is a potential for false positive results.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
There is a potential for false positive results.
There is a potential for false positive results.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
Under certain conditions, there is a risk for a false negative result.
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
