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.
The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.
Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.
VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Autocar is recalling 2020-2026 Legend trucks because cab shock absorber bracket fasteners may detach, creating a road hazard and increasing crash risk.
USDA issued a public health alert for Wegmans frozen chicken nuggets due to possible bone fragments. Consumers should not eat the product.
Forest River is recalling 2025 Coachmen Catalina travel trailers because the Federal Placard lists an incorrect dry weight, which could lead to unintentional overloading.
Winnebago is recalling 2025 Minnie travel trailers because the cooktop flame may invert when the stove and furnace operate simultaneously, increasing the risk of injury or fire.
GiantMouse is recalling about 600 GM12 and GMP12 folding knives because the locking mechanism can fail during use, creating a laceration hazard. No injuries have been reported.
SHEIN Distribution is recalling about 310 Teckwe hair dryer brushes because they lack immersion protection, posing an electrocution or shock hazard if they fall into water while plugged in. No injuries have been reported.
ChrisDowa Roller Window Shades with long operating cords pose strangulation and entanglement hazards to children. About 19,500 units sold on Amazon.com from December 2022 to September 2024.
Duluth Trading recalls about 22,400 children's holiday pajama sets that violate federal flammability regulations for sleepwear, posing a risk of burn injuries to children.
NQDTPBOR multi-purpose helmets for teens do not comply with federal bicycle safety standards for impact protection, stability, labeling, and certification. The recalled helmets, sold on Amazon from May to August 2024, can fail to protect wearers in a crash.
Honda is recalling certain 2025 Acura MDX vehicles because the centre console touchscreen may go blank, so the rearview camera image does not display. This fails FMVSS 111.
Mack is recalling 2010-2025 MRU and Terrapro towing vehicles because they lack the anti-lock brake warning light and circuitry for attached trailers.