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.
Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.
FreshPoint Dallas is recalling specific lots of Roma diced tomatoes due to potential foreign material. The products were distributed in Texas and Kansas.
H & H Remedies, LLC is voluntarily recalling 939 jars of Union (black) salve due to Current Good Manufacturing Practice (CGMP) deviations.
AvKARE Inc. is recalling specific lots of Mesalamine Delayed-Release Tablets because they failed to meet dissolution specifications.
Merete Medical GmbH is recalling 354 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the femur because the product may be mislabeled.
Teva Pharmaceuticals is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets because stability testing revealed out-of-specification dissolution results.
Merete Medical GmbH is recalling 306 units of OsteoBridge Intremedullary Knee Arthrodesis nails because the product may be mislabeled.
H & H Remedies, LLC is voluntarily recalling 252 jars of Vapor Ointment due to Current Good Manufacturing Practice (CGMP) deviations.
Merete Medical GmbH is recalling 215 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the tibia because the product may be mislabeled.
Dole Fresh Vegetables Inc. is recalling specific lots of Aldi and Kroger coleslaw due to a deviation in the wash process that left some product outside company control.
Aesthetics Biomedical is recalling 623 Vivace Electrosurgical Systems because a high-frequency output was not cleared for U.S. distribution.
Merete Medical GmbH is recalling 144 units of OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the humerus because the product may be mislabeled.
Epitope Diagnostics is recalling 2,886 units of its Novel Coronavirus COVID-19 IgG ELISA Kit because deionized water was used instead of distilled water during manufacturing.
USDA FSIS issued a public health alert for Wegmans Beef Culinary Stock imported without re-inspection. No illnesses have been reported.
Medichem S.A. is voluntarily recalling 60,000 kg of Chlorhexidine Gluconate 20% in Alabama, New Jersey, and Texas due to discoloration.
Zydus Pharmaceuticals is recalling 7,908 cartons of Lansoprazole 30 mg tablets because they failed to meet dissolution specifications.
RTI Surgical is recalling 76 units of Streamline OCT Navigated Instruments because the system does not include a drill guide. The devices were distributed to one distributor in Michigan.
Microbiologics Inc is recalling 46 units of a Klebsiella pneumoniae strain because it is VIM-1 negative instead of the expected VIM-1 positive status.
Boston Scientific is recalling eight Model 3300 LATITUDE Programming Systems because a software defect may cause EGM trace channels to display as a flat line during specific tests.
Zydus Pharmaceuticals is recalling 6,840 cartons of Lansoprazole 15 mg tablets because they failed to meet dissolution specifications.
Angiodynamics, Inc. is recalling 32 kits of 5F Standard Micro-Introducer Kits because they may contain a 4F Sheath/Dilator component instead of the correct device.
RTI Surgical is recalling 143 units of Streamline MIS Navigation System Taps because they are not compatible with the Streamline MIS tap sleeve.
Primus Corporation is recalling 97 Ultra2 Resolution Variants Systems because the devices did not receive FDA pre-market approval or clearance.
GE Healthcare is recalling two Aestiva/5 MRI Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.
OriGen Biomedical is recalling six units of 3/8-inch FloPump devices distributed in Texas because the products were expired.