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.
Zimmer Biomet is recalling 23 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed to 18 US states, Japan, and the Netherlands.
BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x90 due to a manufacturing flaw in the sterile barrier system.
Infusion Options, Inc. is recalling various Docetaxel infusion bags in New York due to a lack of assurance of sterility.
Siemens is recalling SOMATOM Edge Plus CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.
Infusion Options, Inc. is recalling HERCEPTIN infusion bags in New York due to a lack of assurance of sterility.
Zimmer Biomet is recalling 28 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed in the US and internationally.
Kerry, Inc. is recalling 104 bags of Predust/Batter due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine states.
Belfonte Ice Cream & Dairy Foods Co is recalling 1,246 units of frozen vanilla yogurt because peanut butter ice cream was placed in the wrong containers.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.
Kerry, Inc. is recalling 258 bags of Breader because the product contains nylon string. The product was distributed to manufacturers and food service distributors in nine US states.
BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x100 due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.
Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.
Siemens Medical Solutions is recalling SOMATOM Confidence CT systems due to four software issues that may cause scan aborts.
Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in scan aborts.
Becton Dickinson is recalling 247,000 blood alcohol test tubes because they lack the required fluoride additive, which may cause inaccurate test results if samples are stored for more than two days.
Siemens Medical Solutions is recalling SOMATOM Force CT systems due to four software issues that may cause scan aborts.
Infusion Options, Inc. is recalling Azacitidine syringes in New York due to a lack of assurance of sterility.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x105 (Item 19669) due to a manufacturing flaw in the sterile barrier system.
Pega Medical Inc. is recalling 19 SLIM Handle components because an internal ring may detach, causing the handle to jam with the driver.
BIMBO Bakeries USA Inc. is recalling 160,000 boxes of Entenmann's Little Bites Soft Baked Cookies due to a manufacturing failure that may have introduced small plastic pieces into the product.
Kerry, Inc. is recalling 4,765 bags of Batter Mix due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine US states.
BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x95 due to a manufacturing flaw in the sterile barrier system.
Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.
NeuroLogica is recalling HS70A Diagnostic Ultrasound Systems due to a potential risk of probes overheating when users decrease the Doppler Sample Volume size in Doppler Only mode.