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.
Baptist Health Medical Towers Pharmacy is recalling 16 bags of Ceftriaxone 2 gram IV solution in Arkansas due to a lack of sterility assurance.
Baptist Health Medical Towers Pharmacy recalls Remicade IV bags in Arkansas due to lack of sterility assurance.
Blue Bell Creameries is recalling 23,973 pints of Rocky Road ice cream sold in Texas and Louisiana because the product may contain undeclared wheat and soy.
Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing discrepant patient results.
Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.
Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.
Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.
Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.
Skytron is recalling 458 EZ Slide Operating Tables because incorrectly manufactured parts may cause the slide cap to detach, risking injury to patients or staff.
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.
Integra LifeSciences is recalling 30,146 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.
Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Kwik Tek is recalling Hammerhead sleds because the front handle bar assembly can break, posing a crash hazard. No injuries have been reported.
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
Baptist Health Medical Towers Pharmacy is recalling ertapenem IV bags in Arkansas due to a lack of sterility assurance.
Ouhlala Gourmet LLC is recalling lemon fruit tartlets because the finished product contains undeclared milk. The recall covers 9,159 cases distributed nationwide and internationally.
Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.
Thule is recalling certain Sprint bicycle carriers because the fork clamping mechanism may not secure the bike, allowing it to detach from the vehicle.
Baptist Health Medical Towers Pharmacy is recalling 0.9% Sodium Chloride IV bags in Arkansas due to a lack of sterility assurance.
Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Baptist Health Medical Towers Pharmacy is recalling Milrinone IV bags in Arkansas due to a lack of sterility assurance.
Focus Bicycles is recalling about 80 Spine mountain bicycles because incorrectly sized seatstay or linkage parts can cause the frame to collapse, posing a fall hazard.
Daimler Trucks North America is recalling 717 Thomas Built Buses because corrosion on the emergency door handle stem could delay evacuation during an emergency.