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.
Active Sports is recalling CTRL Imperial Wakeboard Bindings because the binding can partially detach from the baseplate or the external mount can crack, causing users to lose balance and fall into the water. The company has received 21 reports of detachment or cracking but no injuries have been reported.
Dermoplast FIRST AID spray is being recalled because testing found low levels of one of its two active ingredients. The product was distributed nationwide through internet, distributors, and retailers.
IBSA Pharma has recalled one lot of TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product contained less active ingredient than labeled.
IBSA PHARMA INC is recalling TIROSINT oral solution (Lot #220855) nationwide due to insufficient potency of levothyroxine sodium. The defective lot was voluntarily recalled after manufacturer discovery.
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency—some doses contain insufficient active ingredient. Patients should contact their pharmacist or doctor to verify their medication.
S & MOHR AMERICA recalled approximately 1,320 abm Respiratory Care Standard Breathing Circuits due to incorrect expiration dates printed on product labels. The manufacturing date was printed where the expiration date should appear.
Harbor Freight Tools is recalling replacement lower blade guards for 12-inch Chicago Electric Miter Saws because they do not sufficiently cover the saw blade and can break during use, posing an injury hazard.
Polaris is recalling about 780 Timbersled snow bike conversion kits because a QuickDrive fastener can loosen during operation, causing brake failure and crash risk. No crashes or injuries have been reported.
SCARPA North America is recalling about 770 F1 LT and F1 GT ski boots manufactured in 2022. Screws attaching the ski/walk mechanism can loosen or fall out, causing the mechanism to malfunction and posing a fall hazard.
Consolidated Chemical is recalling Techni-Care Chloroxylenol 3% in 4 oz and 8 oz bottles nationwide due to manufacturing practice violations. No illnesses have been reported.
Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel nationwide due to deviations from proper manufacturing practices.
MEDLINE INDUSTRIES is recalling CENTURION MEDICAL PRODUCTS Circumcision Tray kits (Lot 22HMH649) because the outer packaging is non-sterile, though the surgical contents inside remain sterile.
Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen catheters (Model 80001001) due to incorrect expiration date labeling. The devices expire earlier than the labeled date.
Linus Bike is recalling about 430 electric bicycles (Cesta 500 and Ero 500 models) because the front fork can crack, posing a crash hazard. No injuries have been reported.
Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.
An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.
WeeSprout baby sleep sacks are being recalled because the zipper can detach, posing a choking hazard to infants. The company has received 17 reports of zipper detachment but no injuries have been reported.
Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution due to manufacturing practice deviations. The recall affects 144 bottles distributed in Puerto Rico.
Frenda Corporation is recalling Easy Clean 70% Isopropyl Alcohol due to manufacturing practice deviations. The recall affects 65,376 bottles distributed in Puerto Rico.
DISCOVERY PHARMA LLC voluntarily recalled 21,892 tubes of Conzerol zero molluscum contagiosum topical cream distributed in California, Florida, and Washington due to current good manufacturing practice deviations.
Professional Complementary Health Formulas is recalling Inositol dietary supplement (Lot 1032526, UPC 4065111562) distributed in NY, OR, PA, UT, WI, and WY due to undeclared niacin. Consumers should stop using the product.
Frenda Corporation is voluntarily recalling Easy Clean Isopropyl Alcohol 99%, 1-gallon bottles (164 units) due to current Good Manufacturing Practice deviations. The product was distributed in Puerto Rico, lot C030121.
Frenda Corporation recalls Easy Clean Alcohol Surface Disinfectant Cleaner due to cGMP deviations. The recall affects 8,475 bottles distributed in Puerto Rico.
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.