Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
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.
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.