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For certain nuclear medicine systems, GE Healthcare has become aware that a mitigation may not be correctly implemented. If this is the case, the detector can fall leading to life-threatening bodily injury. Recall start date: December 18, 2022

The replacement silicone sound abatement foam installed into the Trilogy 100 and Trilogy 200 devices identified in this letter may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air…

Philips has identified an issue where a specific component failure in the gradient coil of where the affected 3T MR Systems identified above may act as a heat source, with a potential to produce smoke and/or fire.  If the components failure…

Affected lot may result in a false negative for skin test (peanut allergy).

Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on radiographic imaging. Infolding is different and distinct…

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier…

Affected lot contains active ingredient (Cholecalciferol) levels outside of the labelled claim.

Teleflex has initiated a voluntary field safety corrective action due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an ac power source…

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six…

Affected lot may contain particulate matter  

Jamp Pharma Corporation is recalling one lot (D10776B) of Jamp-Atorvastatin Calcium after one bottle labelled to contain 10 mg tablets of Jamp-Atorvastatin Calcium was found to contain 40 mg tablets of Jamp-Atorvastatin Calcium. Pharmacists may not…

Affected lot may contain the presence of particles

Pharmascience Inc. is recalling one lot of pms-Hydromorphone, 2 mg tablets, (lot 639268) as the bottles may contain hydromorphone tablets of a different strength (8 mg), meaning they contain higher amounts of hydromorphone. Products from the affected lot…

Taro Pharmaceuticals Inc. is recalling all lots of Taro-Zoledronic acid injection 5mg/100mL (DIN 02415100) because they may contain particulate matter. Zoledronic acid is a prescription drug used to treat and prevent osteoporosis and to treat Paget's…

Jamp Pharma Corporation is recalling one lot (MHC1403A) of Jamp-Atorvastatin 40 mg tablets due to possible contamination with latex pieces during manufacturing. A piece of latex was found in one tablet from the affected lot.…