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.
Lotus Mom Corporation is recalling 10 units of a Brass Tope over potential contamination with leachable lead.
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 240 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 553 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Baxter Healthcare is recalling 5 Spectrum IQ Infusion Pumps because they were released without full testing being performed, including occlusion alarm testing.
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip devices due to reports of adverse events.
Medline is recalling 82,597 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5mm, 35 cm, Pistol Grip devices due to reports of adverse events.
Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
Evenflo is recalling LiteMax Factory Select child seats because the Spanish manual lists incorrect weight and height limits, which could lead to improper restraint.
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.
Olympus Corporation of the Americas is recalling Olympus Thunderbeat 5 mm, 35 cm, Inline Grip devices due to reports of adverse events.
Integra LifeSciences Corp. is recalling certain Medihoney Calcium Alginate dressings because packaging failures could lead to a breach in the sterile barrier.