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.
Incomplete seals on the sterile package may compromise the sterility
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.
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.
Incomplete seals on the sterile package may compromise the sterility
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.
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should…
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
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.
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.
Incomplete seals on the sterile package may compromise the sterility
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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 firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.
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.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
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 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.
