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 Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.
Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.
Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.
Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.
TP Orthodontics is recalling 5 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.
Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.
Transonic Systems Inc. is recalling ADT1018 Flow QC Clear Advantage Tubing because the sterility of the device cannot be assured, posing a potential risk of infection.
Ford is recalling 151 2018 F-650 and F-750 trucks because improperly adjusted parking brake cables may cause unexpected vehicle movement, increasing crash risk.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Deerfield Imaging is recalling 10 IMRIS intraoperative MRI systems because magnetic fields cause the IFOSS collision detector control panel to malfunction.
Maquet Cardiopulmonary Ag is recalling 14 units of the Cardiohelp Gas Bottle Holder HKH 8880 because the clamps may crack or break during strong vibrations.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.
National Foodworks Services is voluntarily recalling Soozie's Doozies Sugar Cinnamon Snickerdoodle Cookie Dough due to contamination with Staphylococcus aureus.
Kroger Specialty Pharmacy is recalling Copaxone 40 mg injections due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Zimmer Biomet is recalling Lactosorb RapidFlap bone plates because excessive chamfering on the threads prevents proper engagement with the post component.
Blount Fine Foods is recalling approximately 720 pounds of Chicken Tortilla Soup because the product contains undeclared wheat and may be mislabeled.
Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.
Medtronic is recalling 39 ZEVO Anterior Cervical Plate System slot screws because they are 15mm long instead of the specified 17mm.
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.