Complete FDA and NHTSA recall records dated in January 2024.
These records include useful source details for the selected month.
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity…
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of…
Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause…
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as…
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the…
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity…
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the…
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the…
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the…
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.
