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.
TP Orthodontics is recalling 108 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.
Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Dr. Reddy's Laboratories is recalling Metoprolol Succinate Extended-Release Tablets because a foreign Clopidogrel tablet was found in a bottle.
Siemens is recalling 229 ACUSON SC2000 ultrasound systems because electromagnetic interference from electrosurgical equipment may cause the ECG signal to flatline.
Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.
Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.
Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.
Kroger Specialty Pharmacy is recalling Pulmicort Respules 0.5 mg/2mL due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling one lot of Pulmozyme inhalation solution because it lacks processing controls, which may affect product quality.
TP Orthodontics is recalling five Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Ziegenfelder Company is recalling Sugar Free Twin Pops after Listeria monocytogenes was found in environmental samples at their Denver plant.
Siemens Healthcare Diagnostics is recalling Dimension Vista Ammonia assays because they may produce inaccurate results when used with certain drugs.
Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.
Cook Inc. is recalling 554 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.
Volkswagen is recalling 2011-2017 models including Tiguan, Golf, and CC because internal modifications may prevent them from meeting regulatory requirements, increasing crash risk.
Cook Inc. is recalling 6,345 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
Kroger Specialty Pharmacy is recalling Avonex 30 mcg/0.5 mL PFS Kits due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.