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.
Katadyn North America Foods is recalling 2,719 pounds of Spicy Sausage Pasta because the label lists beef but the product contains pork.
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.
Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.
Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.
Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.
Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.
Kent Precision Foods Group is recalling Orrington Farms Chicken Flavored Broth Base due to incorrect labeling on beef-flavored product.
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.
Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Nature's Way Purewater Systems is recalling Essentia Hydration Perfected Purified Water and Electrolytes because the product may contain mold.
Pfizer is recalling Tikosyn (dofetilide) capsules because they may be cracked or broken. The recall affects 31,569 bottles shipped to 4,447 direct accounts.
ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.
Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.
Biomet Microfixation is recalling 42 total temporomandibular joint replacement systems because laser etching on the parts is wider and deeper than previously validated conditions.
CareFusion 213, LLC is recalling Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, because it contains higher concentrations of available chlorhexidine gluconate than required.
Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated.
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Zimmer, Inc. is recalling 14 Title 2 Bone Screw Remover instruments due to a risk that the weld may break during use, potentially delaying surgery.
Cooper Vision Caribbean Corp. is recalling 1,170 soft contact lenses because portions of the lots may contain units with an incorrect lens axis condition.
Stryker Endoscopy is recalling 1,965 HD 3-Chip Inline Cameras because a colored screen image may occur in certain operating room environments.