All Recalls

Regalo Bakery is recalling Kababayan due to undeclared wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).

Pasta Products which contain cheese may contain undeclared wheat and milk.

Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.

Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.

Customers complained of low/empty reagent vials.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.

AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique.

Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.

BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.

Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.

Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery