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.
Forest River is recalling 2023-2024 Starcraft Starlite and Allstar buses because emergency exit handles are not easily accessible, potentially delaying passenger evacuation.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.
GE Healthcare's Infinia nuclear medicine systems may have been transported without proper detector support, risking detector falls and life-threatening injury. The recall affects 93 units worldwide.
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.
Augustine's HOT DOG temperature management controller (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code 'EA POST' that indicates a diagnostic failure. Approximately 2,271 units have been distributed worldwide.
Hillrom Temperature Management Controller Model 2083516 may experience a power-on self-test error code 'EA POST' during startup. The recall affects 77 units distributed worldwide.
Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.
Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.
Cardinal Health Presource surgical kits are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.
Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.
GE Healthcare recalls certain Infinia II and related nuclear medicine systems that may have been transported without proper detector support. This risk of detector fall could cause life-threatening bodily injury.
Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.
A software defect in McKesson Cardiology Hemo's autosave mechanism may cause clinicians to administer incorrect medications. The FDA has issued a Class II recall.
Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.
Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.
GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
Intuitive Surgical is recalling 373 Resano Forceps due to increased complaints of frayed or broken grip cables on the reusable surgical instruments. Affected healthcare providers should contact the manufacturer for guidance.