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.
Volvo Trucks is recalling certain 2020 and 2021 VNL and VNR trucks because steering gear fasteners may not have been properly tightened. Loose fasteners could result in loss of vehicle control, increasing crash risk.
Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.
Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate inspection of thermistor sensors.
Boston Scientific is recalling 5 units of Percuflex Plus Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.
Boston Scientific is recalling 91 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Synaptive Medical Inc is recalling 28 units of ImageDrive Clinical software due to a defect that degrades mammogram image quality, potentially leading to misdiagnosis.
Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.
Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.
Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or lost samples.
Medivators is recalling Endo SmartCap Tubing because a manufacturing anomaly may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection was used on the thermistor sensors.
Smith & Nephew is recalling FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.
Boston Scientific is recalling Sensor Nitinol Wires because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with software below 3.4MR2 because the barcode reader may misinterpret labels, risking patient mixups and delayed treatment.
Boston Scientific is recalling 19 Polaris Ultra Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Synaptive Medical is recalling ClearCanvas RIS/PACS software because a defect affects mammogram image quality, potentially leading to misdiagnosis.
Beckman Coulter is recalling 291 Power Express Sample Processing System units due to a software design problem that causes sample splashing and potential biohazard exposure.
Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.
Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.
Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.