Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Medline is recalling over 840,000 pill splitters due to a defect where the product lid can come unhinged, exposing a sharp blade and posing a laceration risk.
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.
Be Happy Cakes is recalling Kristi's Key Lime Cookies because they contain undeclared soy and sulfite allergens. Consumers allergic to soy or sulfites should not consume this product.
Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French due to an expiration date mismatch between the sterile barrier pouch and case labels. The discrepancy allowed product to be used up to five days past its true expiration date.
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.
Southeast Toyota Distributors is recalling 2020-2022 Toyota 4Runners with 20-inch Black Gunner Wheels due to incorrect load capacity labels that could lead to vehicle overloading and increased crash risk.
GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.
Honey Heaven Wholesale Inc is recalling 48 bags of walnut product labeled as Nutritional Yeast due to mislabeling. The misidentification poses a potential allergen risk to consumers with tree nut allergies.
Blue Kuna BBQ Sauce labeled as vegan contains anchovies (fish), a common allergen. This mislabeling poses a risk to consumers with fish allergies.
Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.
The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.
Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.
Wilton Industries recalled 16,281 units of Wilton Rainbow Sprinkles Mix due to milk contamination. The affected lots are 21005Z and 21111Z.
Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.
PurAqua Belle Vie Sparkling Water with Ashwagandha contains undeclared caffeine. The product was distributed to 17 states and poses potential risk for caffeine-sensitive consumers.
RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.
Lippert is recalling electric retractable awnings up to 18 feet long because a welded seam may separate, allowing the awning to drop and increase injury risk.
The 2022 Oliver Travel Trailers Legacy Elite II may have a cracked bearing washer in the hub assembly that could cause the hub to separate from the axle, risking loss of vehicle control. Owners should contact Oliver at 1-866-205-2621 for a free replacement.
The engine wiring harness may be damaged in 2022 Subaru Outback vehicles, causing a loose connection to the engine control unit. This could cause engine stalls and increase crash risk.
Altec Industries is recalling 2016-2022 AT200A and AT30-G vans because a faulty outlet may fail to protect against electrical overloads, increasing fire risk.
Kids Tales-branded children's pajamas fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 9,100 units sold online at Amazon from November 2021 through April 2022 are affected.
Daimler Trucks is recalling certain 2022 Freightliner Cascadia trucks because the electronic parking brake may fail to engage when turned off, risking vehicle rollaway. Owners should contact dealers for free repair.