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.
25,676 detailed records are currently available in this category.
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C…
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C…
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Firm has received reports of leading end catheter component separations.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The lot contained two outer pins instead of one outer and one inner pin.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C…
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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.
