Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
24,239 detailed records are currently available in this category.
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
There is a potential for false positive results.
There is a potential for false positive results.
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…
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.
There is a potential for false positive results.
Customers were not notified of previous recalls associated with various defibrillator models.
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…
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
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
There is a potential for false positive results.
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Missing splash guard which may expose users to hazardous materials. .
Customers were not notified of previous recalls associated with various defibrillator models.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
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.
Customers were not notified of previous recalls associated with various defibrillator models.
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
