Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
South Coast Specialty Compounding is recalling Bi-Est and Progesterone Vaginal Suppositories due to potential penicillin cross-contamination.
South Coast Specialty Compounding is recalling Tri-Est 80:10:10 capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
South Coast Specialty Compounding is recalling five prescriptions of Bi-Est hormone drops due to potential penicillin cross contamination.
Westbrook's Cannery is recalling 12-ounce jars of Dilly Beans because they may be underprocessed. The product was distributed to 11 states.
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
South Coast Specialty Compounding is recalling Bi-Est 80:20 Progesterone capsules due to potential penicillin cross-contamination.
Customed, Inc. is recalling 192 D & C Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling Methyl Folate Injection vials due to potential penicillin cross-contamination. The recall covers 335 vials distributed nationwide.
South Coast Specialty Compounding is recalling Meloxicam 12 mg capsules due to potential penicillin cross contamination. The recall covers all lots expiring in August 2015.
Customed, Inc. is recalling 84 units of Laparoscopy-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.
South Coast Specialty Compounding is recalling 61 prescriptions of Estriol and Estradiol cream because the products may be contaminated with penicillin.
South Coast Specialty Compounding is recalling Chorionic Gonadotropin/Hydroxocobalamin Injectable vials due to potential penicillin cross-contamination.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Panoramic Rental Corp. is recalling 7,885 Panoramic X-ray Model PC-1000 units due to a jackscrew nut part failure that could cause device malfunction and injury.
Olli Salumeria Americana is recalling pork salami products because the packaging lacks an ingredient list, failing to disclose the presence of sulfites from wine.
Schrader Farms is recalling approximately 20 pounds of ground beef sold in Seneca County, New York, due to possible non-O157 E. coli contamination.
Cummins is recalling certain ISB6.7, ISL9, ISX12, and ISX15 engines because a faulty Engine Control Module may cause the engine to stall without warning, increasing crash risk.
New Flyer is recalling 432 transit buses from 2013-2015 because a tie rod clamp may be improperly torqued, risking a loss of steering.
Keystone is recalling 2008-2009 travel trailers and fifth wheels because a transfer switch may overheat and cause a fire.