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.
Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.
O'Brien's Own Gourmet Granola (busy bee's honey & oat, 12 OZ) is being recalled because the product contains whey but does not declare milk on the label. Consumers with milk allergies or sensitivities are at risk.
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Clio LLC is recalling Peanut Butter Greek Yogurt Bars due to the possible presence of metal fragments. The affected product was distributed nationwide with best-buy dates between March 7, 2021 and June 20, 2021.
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
Auranso Official children's nightgowns sold on Amazon fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 8,000 units distributed January–June 2021 are affected.
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Clio LLC is recalling Clio Coconut Greek Yogurt Bars in 50g x 10-pack format due to the possible presence of metal fragments. The product was distributed nationwide.
SIORO-branded children's robes sold on Amazon from December 2020 through April 2021 fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries to children.
Clio LLC is recalling Clio Strawberry Greek Yogurt Mini Bars (6.2 oz pouch x 6 pouches per case, UPC 854021008084) with best buy dates between 2/7/2021 and 6/27/2021 due to possible metal fragments.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Peanut Butter Monster Trail Mix because the product may contain stringy pieces of flexible plastic. The affected product was distributed nationwide.
UPPAbaby is recalling approximately 86,000 RumbleSeat adapters that can detach from strollers, posing a fall hazard to children. The company has received 135 reports of detachments, including injuries such as bumps, scrapes, and two broken noses.
Dominguez Foods of Washington is recalling Su Cocina Pan Molido bread crumbs because the label declares whey but does not declare milk, posing a risk to consumers with milk allergies.
Clio LLC is recalling Clio Mixed Berry/Peach Greek Yogurt Bars sold at Costco due to possible metal fragments in the product. Consumers should not consume the affected items.
Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.
Clio LLC is recalling Raspberry/Peach Sams Mini Club Yogurt Bars due to the possible presence of metal fragments. The recalled product was distributed nationwide.
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.
Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Clio LLC is recalling Clio Greek Yogurt Bars (50g x 10 retail packs) distributed nationwide due to the possibility of metal fragments in the product.
Exact Medical Manufacturing is recalling the Hays Innovation Ultrasound Probe Cover Kit because it lacks required FDA 510(k) clearance for use in body openings.
Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Medical Action Industries is recalling 31 cases of Minor Procedure Trays because hemostats in the kits may have flaking metal or brown spots that could compromise sterile surgical procedures.