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.
Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.
A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.
Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.
Kumpunny's LLC is recalling Lemon, Sage Parmesan & Romano Cream Sauce because the label does not declare milk, which is present in the product as heavy cream and butter.
Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.
CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Cannula due to potentially inadequate sterilization of certain lots. Affected units were distributed to medical facilities in the US and internationally.
CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.
Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit due to products potentially lacking adequate sterilization. The 15 units affected (Lot 20071774, 19123262) were distributed nationwide.
K2M, Inc. is recalling Cascadia AN Interbody Convex lumbar implants due to incorrect dimensions listed on product labels for specific lot numbers and device sizes.
Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 units distributed nationwide.
Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.
Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.
Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.
Zavation is recalling 79 units of the ZVplasty 10G, 15mm Single Balloon Kit due to inadequate sterilization. Affected devices may pose a contamination risk for patients undergoing spinal procedures.
Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.
Zavation is recalling 24 units of the ZVplasty System used in orthopedic and spinal procedures due to potential inadequate sterilization. Patients who received recalled devices should contact their healthcare provider.
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.
Zavation is recalling 10G beveled trocar/cannula instruments used in orthopedic and spinal procedures due to potential inadequate sterilization, creating infection risk.
CamelBak is recalling certain caps sold with Podium and Peak Fitness water bottles because a small silicone valve can come loose and detach, posing a choking hazard. No injuries have been reported.
Zavation recalled 14 units of ZVplasty Bipedicular Cement Delivery Cannula Kits distributed nationwide because they may not have been adequately sterilized.
Clio LLC is recalling Clio Yogurt Bar Raspberry/Peach Mini Club pack (24g x 24) due to possible metal fragments in the product.
Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet sterility standards.
Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.
Zavation recalls ZVplasty 10G, 10mm Double Balloon Kits used in spinal surgery due to potential inadequate sterilization. Seven units distributed nationwide may not have met sterility standards.
Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they may not have been adequately sterilized.