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All product recalls associated with Ethicon, Inc. US.
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
The product performance fails due to precipitation of the R2 component.
Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.
Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.
The product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
A manufacturing defect may prevent adequate sterilization of the entire device.
A manufacturing defect may prevent adequate sterilization of the entire device.
A manufacturing defect may prevent adequate sterilization of the entire device.
A manufacturing defect may prevent adequate sterilization of the entire device.
The R1 reagent has microbial contamination.
A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.
Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required, which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.
A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.
Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
Image may appear dark, requiring repeat image acquisition.