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.
Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.
Keystone RV Company is recalling 2019-2020 Hideout 25TH toy haulers because they may be missing a required warning label in the garage area.
BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system that may compromise sterility.
Elekta is recalling 374 iGUIDE Systems because they may incorrectly monitor 3D position. The recall covers devices distributed nationwide and worldwide.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x115 due to a manufacturing flaw in the sterile barrier system. The devices are intended for orthopedic surgical procedures.
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 2.5x170mm due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x30 due to a manufacturing flaw in the sterile barrier system.
Siemens Medical Solutions is recalling SOMATOM Drive CT systems due to four software issues that may cause scan aborts.
Amy's Kitchen Inc. is recalling 5,207 cases of Broccoli & Cheddar Bake due to consumer complaints of black plastic found in the product.
Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling preservative-free 0.9% sodium chloride 5 mL syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling multiple Trastuzumab infusion bags in New York due to a lack of assurance of sterility.
BMW is recalling 2019 Rolls-Royce Cullinan vehicles because brake lights may not be bright enough, increasing crash risk.
Siemens is recalling SOMATOM Definition Flash CT systems due to four software issues that may cause scans to abort.
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x36 due to a manufacturing flaw in the sterile barrier system.
Siemens Medical Solutions USA is recalling SOMATOM Definition AS CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x110 due to a manufacturing flaw in the sterile barrier system.
Infusion Options, Inc. is recalling various Cyclophosphamide infusion products in New York due to a lack of assurance of sterility.
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.1x150mm due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x34 due to a manufacturing flaw in the sterile barrier system.
Hill & Valley Inc. is recalling Freshness Guaranteed Chocolate Chunk cookies due to undeclared milk and soy allergens.
The FDA is recalling DARATUMUMAB infusion solutions because sterility cannot be assured, creating a potential infection risk.
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.6x150mm due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system.