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.
Piantedosi Baking Co. recalls Gourmet Potato Deli Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected frozen products distributed across 15 states; consumers should check lot codes 22081-22115 with March-April 2023 expiration dates.
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Charlie's brand Spinach Salad With Honey Dijon Dressing is recalled due to undeclared fish (anchovy) in the Worcestershire sauce dressing. Consumers with fish allergies are at risk.
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
Select Bakery Old Fashion Pound Cake is recalled due to undeclared Yellow #5, Yellow #6, and Red #40 artificial colorants. Affected product was distributed to Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
Volkswagen is recalling certain 2022 Taos vehicles with all-wheel drive due to engine control unit software that may cause engine stall when coming to a stop, increasing crash risk. Dealers will provide free software updates.
Piantedosi Baking Co. is recalling frozen Gourmet Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 units across 15 states.
Piantedosi Baking Co. is recalling 18,119 frozen Brioche-Style Slider Roll 24-packs distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.
Select Bakery Gourmet Banana Nut Pound Cake contains undeclared soy, posing a risk to consumers with soy allergies. The product was distributed in Georgia, North Carolina, and South Carolina.
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
Piantedosi Baking Co. is recalling Brioche Style Burger Rolls (UPC 033474504170) distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Piantedosi Baking Co. is recalling frozen Gourmet Potato Slider Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 18,119 product trays were distributed across 15 states.
Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
Select Bakery Peanut Butter DELIGHT (3 oz packages) is recalled because it contains undeclared soy and Red #40. The product was distributed to Georgia, North Carolina, and South Carolina.
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
Piantedosi Baking Co. is recalling 18,119 trays of frozen finger rolls distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.
B & W Gourmet Burger Rolls are being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across 15 states.
Piantedosi Baking Co. is recalling Split Top Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across multiple northeastern and southeastern states.