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.
Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified. The products were distributed to 41 US states.
Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.
Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number ST503004541) because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a material different from the applicable specifications.
Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.
Neusoft Medical Systems is recalling six NeuViz 128 CT scanners due to a software defect that may cause image loss during specific scans.
CooperSurgical is recalling 480 ICSI Micropipettes because the required thirty-degree bend is absent. The affected units were distributed in Denmark, Italy, and Sweden.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the applicable specifications.
Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.
Blount Fine Foods is recalling specific lots of Panera Bread at Home Chicken Tortilla Soup due to possible plastic contamination. No illnesses have been reported.
Back Roads Food Company is recalling specific lots of Ancient Grains Granola because the products may contain pieces of aluminum.
Integra Limited is recalling 274 units of Integra Flowable Wound Matrix (Lot 2991332) because the product failed stability testing for visual appearance and force displacement.
Associates of Cape Cod, Inc. is recalling Fungitell Kits due to potential missing or incorrect components.
Barlean's is recalling specific flax oil softgel supplements due to undeclared sulfites. The FDA classifies this as a Class III recall.
Unipharma, LLC is recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution due to potential contamination with B. cepacia bacteria.
Opgen Inc is recalling 80 GNR PNA FISH Control Slides because they may show diminished performance before expiration, potentially causing invalid test results.
Barlean's is recalling Essential Woman softgels due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.
Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to potential contamination with B. cepacia bacteria.
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Healthy Life Snacks is recalling Tropical Trail Mix because it contains undeclared sulfur dioxide. The product was distributed in Massachusetts and Rhode Island.
Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough due to potential contamination with B. cepacia bacteria.
Back Roads Food Company is recalling Maple Spice Granola because the product may contain pieces of aluminum.
Barlean's is recalling Ultra EPA-DHA Fish Oil softgels due to undeclared sulfites. Sulfite levels are below 10 ppm.
Barlean's is recalling Master Blend Total Omega 3.6.9 Lemonade Flavor softgels due to undeclared sulfites. The product was distributed nationwide.