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.
Siemens Medical Solutions is recalling nine Artis Zee Angiographic x-ray systems due to an inappropriate cable connection that may cause system failure and restricted gantry maneuverability.
Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.
J.P. Boden is recalling specific boys' pajama sets because they fail to meet federal flammability standards, posing a risk of burn injury to children.
Teleflex Medical is recalling 55,521 Weck Vista Universal Cannulas because they may leak insufflation gas during use.
Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to complaints of insufflation gas leakage.
Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.
Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.
Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.
Laboratories Cop Inc is recalling Ideal Protein Double Chocolate Brownies due to possible contamination with thin metal fragments.
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.
Roos Foods Inc. is recalling all brands and sizes of Crema Pura Mexicana cultured sour cream because samples of a related cheese product tested positive for Listeria monocytogenes.
Allesee Orthodontic Appliances is recalling 411 Jet appliances because a missing screw collar may prevent intended tooth movement.
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to complaints of leakage of insufflation gas through the device.
3M is recalling Steri-Vac Gas Sterilizers due to a rare failure that could cause ethylene oxide exposure. The issue affects specific models manufactured in late 2006 and 2007.
Siemens is recalling ACUSON P300 ultrasound systems with PA230 transducers because they may exceed maximum allowable surface temperature limits.
Ormco/Sybronendo is recalling 150 Spirit MB Orthodontic Brackets because a misplaced ID dot may cause incorrect tooth placement.
Siemens Medical Solutions Diagnostics is recalling 1,006 IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems due to a potential for incorrect test results.
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.
Infantino LLC is voluntarily recalling 144,000 units of the Squeeze & Teethe Monkey teething ring because the tail may pose a choking hazard to young children.
Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.
Harley-Davidson is recalling 2013-2014 FXSB and FXSBSE motorcycles because suspension variances may cause the fuel level sensor to read inaccurately, potentially leading to unexpected stalling.
PACCAR is recalling 2014-2015 Peterbilt 587 trucks because a software malfunction may cause fog lights to turn on with high beams, potentially blinding oncoming traffic.
Honda is recalling 2014 Odyssey vehicles because a damaged electrical connector may prevent the passenger-side side curtain air bag from deploying in a crash.
Ducati is recalling 2012-2013 1199 Panigale motorcycles because a wiring issue may disable the horn, high beam, and right turn signals, increasing crash risk.
Mazda is recalling approximately 19,000 2014 Mazda6 vehicles because the fuel tank can be overfilled, potentially causing gas to leak and increasing fire risk.