Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Vision RT is recalling 56 AlignRT InBore systems because information identifying the lasers and their characteristics was omitted from the Instructions for Use.
Goodyear is recalling specific Cooper Discoverer SRX tires because incorrect Tire Identification Numbers prevent proper registration and compliance with federal safety standards.
Zydus Pharmaceuticals is recalling 2,136 bottles of traZODONE Hydrochloride Tablets, 100mg, after a product complaint that some tablets had a dent on the plain side of the tablet surface.
Datascope is recalling 11,470 Cardiosave Hybrid units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Datascope is recalling 47 Cardiosave Rescue units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Datascope is recalling 47 Cardiosave Rescue Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.
GE Medical Systems is recalling 1,818 Senographe Pristina mammography systems because some have a missing or incorrect X-Ray Warning label.
Datascope is recalling 11,470 Cardiosave Hybrid Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.
Aizu Olympus is issuing a recall covering 6,578 OER-Pro units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Aizu Olympus is issuing a recall covering 6,578 OER-Mini units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Aizu Olympus is issuing a recall covering 6,578 OER-Elite units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Polymedco is recalling 403 units of OC-Auto FOBT-CHEK Negative Controls because the kit box and vial labels state an expiration date of 2026-01-16 instead of 2027-01-17.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.
Home Health US is recalling 4,661 One Step Sterile Lancets because of incorrect or missing Unique Device Identifier codes.
NAFCO is recalling 141 cases of frozen whiting fillets because the retail bags carry a best-by date of 1-11-2025, implying the product is expired when it is good until 1-11-2027.
Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.
FloPatch FP120 flowmeter patches, lot 03250602, are recalled because the human readable expiry date on the outer shipping packaging reads 2025-06-20 when it should read 2026-06-20. 9 units are affected.
C10-3v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
V6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C9-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
c5-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
L15-7io Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.