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.
Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Apotex is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution 0.5% because atypical weight loss from improper bottle sealing raises sterility concerns.
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
9,657 bottles of raspberry flavored vitamin B12 gummies sold as Black Girl Vitamins and Rise-N-Shine are being recalled because the product may contain undeclared peanuts.
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.
Kroger is recalling 8,400 cases of shrimp cocktail bowls made under insanitary conditions in which the product may have been contaminated with Cesium-137.
Gina Marie Bakery is recalling 172 cases of Italian Sesame Cookies for undeclared sesame along with undeclared Yellow 5, Red 40 and Yellow 6.
Winnebago is recalling 2025 Access recreational trailers because the shelf above the bed may detach, posing an injury risk to occupants.
PepsiCo is recalling 2,854 cases of Lipton tea because bottles labeled Diet Green Tea Mixed Berry with 0g sugar contain Green Tea Citrus with 25g sugar.
Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Gina Marie Bakery is recalling 172 cases of Italian Mixed Vanilla Cookies for undeclared almonds and sesame along with undeclared Red 40, Red 3 and Blue 1.
Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.
Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.
bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.
Kroger is recalling 4,871 cases of frozen cooked tail-on shrimp made under insanitary conditions in which the product may have been contaminated with Cesium-137.
Continental is recalling specific tire models because the wrong rubber compound was used, which may cause the tread to detach and increase crash risk.
S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.
Five cases of frozen raw easy peel shrimp are being recalled after product that was on FDA hold for high levels of nitrofuran was inadvertently distributed.
USDA FSIS issued a public health alert for FreshRealm ready-to-eat meals containing riced cauliflower that may be contaminated with Listeria monocytogenes.
Chrysler is recalling specific Mopar Radios because the rearview camera image may not display properly, increasing crash risk.