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 Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.
Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
Philips is recalling 796 Cardiac Workstation 5000 units worldwide because they may intermittently provide inaccurate native heart rate data.
Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
Intersurgical Inc is recalling 1,575 One-Piece Guedel Airway devices because they could potentially be occluded or partially occluded.
Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.
Bell Sports is recalling specific Pit Boss helmets that may lack proper impact protection, increasing injury risk in crashes.
Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.
Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.
Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.
Gifford's Dairy is recalling specific lots of HomeMaine Power Play Fudge ice cream due to potential rubber contamination.
restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.
Boston Scientific is recalling OverStitch Suture Cinch devices because they may fail to deploy the implant or cut the suture as intended.
Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.
Philips is recalling 1,810 Cardiac Workstation 7000 units because they may intermittently provide inaccurate native heart rate data.
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
Medtronic is recalling 16 MiniMed 640G insulin pumps distributed in Europe because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.
Nutrient Foods, LLC is recalling 16 kits of Protein Cereal Cocoa Crunch because soy was not declared in the contains statement.
AVID Medical, Inc. is recalling 40 packs of Halyard LAVH PACK kits because a component was improperly sterilized, potentially causing leaks.
Sun Pharmaceutical Industries is recalling 1,968 bottles of Carbamazepine 200mg tablets due to CGMP deviations and black spots found on tablets.