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.
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF…
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF…
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in…
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the…
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated…
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Out of Specification
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
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.
