Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Magellan Diagnostics is recalling 321 LeadCare II Blood Lead Test Kits due to a potential expiration date labeling error that may delay test results.
Mindray DS USA, Inc. is recalling cPM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Medical Action Industries is recalling Urinary Clean Catch kits due to an internal data-entry error that resulted in an incorrect expiration date on the label.
Mindray DS USA, Inc. is recalling Passport Series Patient Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Mindray DS USA is recalling ePM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Mindray DS USA, Inc. is recalling 133 BeneView T5 and T8 operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Sun Pharmaceutical Industries Inc. is recalling Tretinoin Cream 0.05% because it failed impurities and degradation specifications.
Sun Pharmaceutical Industries Inc. is recalling Tretinoin Cream USP 0.05% because the product failed impurities and degradation specifications.
Mindray DS USA, Inc. is recalling Panorama and Telemetry Monitoring System operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Certain operator's manuals for Mindray BeneVision N1 and N-Series patient monitors contain descriptions that may be insufficient or need clarification about selected physiological alarm functions.
Mindray DS USA, Inc. is recalling BeneVision Series Telemetry Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Sun Pharmaceutical Industries Inc. is recalling Tretinoin Cream USP, 0.05%, 45 g tubes, Lot # AD96183, due to failed impurities and degradation specifications.
Mindray DS USA, Inc. is recalling T1 Patient Monitor Operator's Manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
HeartSine Technologies is recalling 31,834 public access defibrillators distributed without the required Maintenance Supplement, which describes an extra check every 3 months.
Karl Storz Endoscopy is recalling six HOPKINS Telescope eyepieces because of incorrect inside packaging labels. The units were distributed in Arizona, California, and Missouri.
Macleods Pharmaceuticals is recalling Olanzapine 5 mg tablets because organic and unspecified impurities exceeded specifications.
ImprimisRx NJ LLC is voluntarily recalling 772 bottles of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution because the drug is subpotent.
Wonton Specialist Inc. is recalling Pan Fried Noodles due to undeclared FD&C Red No. 40. The product was distributed in New York, New Jersey, and Pennsylvania.
Chiesi USA is recalling 3,002 vials of Revcovi (elapegademase-lvlr) injection because the product failed stability specifications for protein concentration.
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) extended-release capsules because they failed dissolution specifications. The recall covers 11,304 bottles distributed nationwide.
American Health Packaging is recalling 10,953 cartons of Buprenorphine Sublingual Tablets due to a label mix-up. The affected lot is distributed nationwide.
B Braun Medical Inc is recalling specific lots of Discofix Four Way Stopcock Extension Sets because the carton shipper labels display an incorrect expiration date.
Prospector Popcorn is recalling 21,400 units of Maple Walnut Ice Cream Gourmet Popcorn due to inaccurate nutrient declarations for potassium, calcium, and iron.
Prospector Popcorn is recalling Belgian Chocolate Toffee Gourmet Popcorn due to inaccurate nutrient declarations for Iron and Vitamin D.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.