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.
C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.
C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise the sterile barrier.
C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were distributed nationwide.
Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.
General Motors is recalling 2021-2022 Chevrolet Silverado and GMC Sierra pickup trucks due to brake modulator bolts that may fail to seal properly. Water intrusion can cause electrical short circuits, creating a fire risk.
Baker's Corner Bakery is recalling Oatmeal Butterscotch Cookies (12 oz bags) because soybean oil in the shortening and milk in the butterscotch chips are not declared on the label, posing a risk to consumers with allergies.
Macy's is recalling Martha Stewart Collection Oil & Vinegar Cruets because the glass portion can break during use, causing cuts. Six incidents have been reported, including three lacerations with two requiring stitches.
Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.
Venom Motorsports is recalling about 500 youth all-terrain vehicles (ATVs) because they do not meet mandatory safety requirements, including speed restrictions, and were distributed without CPSC approval. The recalled ATVs pose a risk of serious injury or death.
The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.
C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.
Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.
Baker's Corner Bakery is recalling Oatmeal Cranberry Cookies because soybean oil is not declared on the label, despite being present in the shortening ingredient. Consumers with soy allergies may be at risk.
C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.
GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.
Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.
Greiner Bio-One is recalling 956,400 VACUETTE coagulation blood collection tubes that may clot due to anticoagulant variation or low vacuum.
C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.
C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.
Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.
Jayco is recalling certain 2019-2021 Entegra and Jayco Class A motorhomes because the instrument cluster may go blank while driving, potentially hiding speed and warning lights.
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.
Argon Medical Devices is recalling the Scorpion Portal Vein Access Set due to design changes that have caused the sheaths to crack or break at the tips. The affected product was distributed in the United States.
Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.