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All product recalls associated with CP Medical Inc.
Total Recalls
57
Past Year
2
Class I (Serious)
3
Most Recent
Oct 2025
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.
Failed to meet USP minimum average value for knot pull (tensile) strength.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.
Non-Sterility: The recalled lot failed sterility testing.
ERGO Release 1.6.3 is overestimating the MU values.
Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.
In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.
Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to
Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.
The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re
Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied t
Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.