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.
KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.
Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.
Guerbet LLC is recalling 3,140 prefilled sodium chloride syringes because an RFID formatting error prevents the Optivantage injector from administering the product.
Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) 240 mg tablets because the lot was not intended for commercial distribution.
Frito-Lay is recalling 95,412 jars of Tostitos Medium Salsa Con Queso because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.
ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.
Frito-Lay is recalling Tostitos Medium Chunky Salsa in glass jars because a packaging defect may affect the vacuum seal and cause spoilage.
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.
Frito-Lay is recalling Tostitos Medium Queso Blanco Dip because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.
CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.
Pfizer is recalling 7,824 bottles of ethosuximide capsules because the expiration date on the label is incorrect.
Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.
EPI Health is recalling 1,626 bottles of Minolira extended-release tablets because they failed dissolution specifications. The recall is limited to EPI field representatives.
Pfizer is recalling 7,686 bottles of Zarontin (ethosuximide) capsules because the expiration date on the label is incorrect.
Philips Healthcare is recalling two DigitalDiagnost C50 stationary X-ray systems in Puerto Rico due to a missing label identified during recent evaluations.
Randox Laboratories is recalling Randox Urinalysis Control Level 2 kits because the leukocyte range for the Siemens Multistix method was incorrect.
CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.
Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.
Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify tether removal during implant.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.
American Health Packaging is recalling Lamivudine Tablets due to an error in the package insert that incorrectly lists tablet description coding.
Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.