Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Cardiac Science is recalling five Powerheart G5 AEDs because sub-supplier documentation is insufficient to verify that the printed circuit boards conform to specifications.
Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.
InvaGen Pharmaceuticals is recalling 1,776 bottles of Testosterone Topical Solution because defective containers may cause the actuator to function improperly, affecting dose delivery.
Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.
Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.
Fairmont Foods is recalling ready-to-eat pork and beef gravy products due to possible contamination with clear pliable plastic. No illnesses have been reported.
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.
Qiagen is recalling 31 units of the RNeasy DSP FFPE Kit because a contaminant in the deparaffinization solution reduces RNA purification efficiency.
Simply Fresco LLC is recalling Full Circle Market Garden Style Salsa, Mild, 16 oz jars due to potential foreign material up to 3 mm in diameter.
Simply Fresco LLC is recalling 54 cases of Full Circle Market Garden Style Salsa, Medium, 16 oz jars, due to potential foreign material up to 3 mm in diameter.
Tecan US, Inc. is recalling 40 Freedom EVO 200 laboratory robots because gas springs were not always replaced within the specified interval.
Medtronic is recalling 15 Hancock II T510 Mitral Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.
GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Medtronic is recalling 15 Hancock II T510 Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Hank's Cheesecakes, LLC is recalling Cream Cheese Brownies because the packaging lacks labels indicating ingredients or major food allergens.
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to cleaning procedure failures that may have caused cross-contamination.
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Arrow International Inc is recalling 450 units of Arrowg+ard Blue Advance PICC devices due to incorrect expiration dates.
Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.
Arrow International Inc is recalling Arrowg+ard Blue Advance JACC products due to an incorrect expiration date. The recall involves 174 units distributed nationwide.
Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.