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.
Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.
Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.
Mount Franklin Foods is recalling three varieties of honey roasted cashews nationwide due to undeclared soy and wheat allergens caused by mislabeling.
Mount Franklin Foods is recalling Circle K Honey Roasted Peanuts nationwide due to mislabeling that may result in undeclared soy and/or wheat allergens. Consumers with allergies to these substances should not consume this product.
TRP Natural Eyes Sterile Eye Ointment is recalled due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.
Somebody's Mother's White Chocolate (9.5 oz jars, Lot 060723) sold in Texas is being recalled because soy is not declared on the label. The undeclared allergen poses a risk to consumers with soy allergies.
Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.
Somebody's Mother's Island Sauce is recalled due to undeclared soy. Consumers with soy allergies may have an allergic reaction if exposed to this product.
Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.
Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.
AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.
TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.
Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.
Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.
Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.
Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.
TRP Natural Eyes sterile eye drops are being recalled because the manufacturer cannot assure the product maintains sterility. The recall involves 196,111 units distributed to retailers in Rhode Island and Colorado.
Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.
Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.
Southern Taiwan LLC is recalling Radish Turnip Cake distributed in Washington due to undeclared wheat starch and sulfites. The product poses a risk to consumers with wheat or sulfite allergies.
Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.
Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.