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.
American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.
Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.
Chemi-Source Inc is recalling Low Carb Protein products because the whey ingredient is not listed as milk, a major allergen.
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Chemi-Source Inc is recalling Low Carb Protein - French Vanilla because the whey and casein ingredients are not listed as milk, a major allergen.
Chemi-Source Inc is recalling All Natural Whey protein products because the milk allergen was not listed on the label.
Chemi-Source Inc. is recalling All Natural Gainer protein powder because the milk ingredient was not listed on the label, posing a risk to consumers with milk allergies.
Gyrus Acmi is recalling disposable myringotomy knives because they may lack sterility assurance. The affected units were distributed in the US, Canada, and the UK.
Chemi-Source Inc is recalling Isolate Whey Protein Chocolate Malt because the whey ingredient was not listed as milk, a major allergen.
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Chemi-Source Inc. is recalling 2,932 units of 100% Micellar Casein (Rich Chocolate) because the milk ingredient was not listed as an allergen.
Chemi-Source Inc. is recalling Massive Muscle Gainer weight gainer because the milk ingredient was not listed as an allergen, posing a risk to consumers with milk allergies.
Chemi-Source Inc. is recalling Flax-N-Whey products because the whey ingredient contains milk, a major allergen, that is not listed on the label.
Salsa Cycles is recalling specific Vaya and La Cruz bicycle forks because they can bend above the disc brake mount, posing a fall hazard to riders.
Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
Chemi-Source Inc. is recalling Metabolic Whey protein powder because the packaging fails to list milk and soy as ingredients. Consumers with allergies to these substances are at risk of serious allergic reactions.
Chemi-Source Inc is recalling Sprouts Farmers Market Whey Protein Chocolate because the whey ingredient was not listed as milk, a major allergen.
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN tablets because the products are underdosed or have an incorrect dosage regime.
GE Healthcare is recalling 800 reusable CO2 absorbent canisters used with anesthesia systems because they may not seal properly.
Hill-Rom is recalling 412 SlingBar Wide 670 patient lifts because a retrospective review found a potential for impalement if a person falls onto the hooks.
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Chemi-Source Inc. is recalling 1,182 units of Micellar Casein powder because the milk ingredient was not listed as an allergen.
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently during surgery.
Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.