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.
Hobbs Medical is recalling Biliary Pigtail Stent Kits with incorrect expiration dates on labels. The incorrect dates extend the product shelf life, potentially allowing devices to be used past their actual expiration.
Hobbs Medical is recalling polypectomy snares with incorrect expiration dates on labels. Affected devices have lot numbers ending in R and were distributed from March 2018 to September 2020.
Hobbs Medical is recalling Helical Retrieval Baskets due to incorrect expiration dates on device labels. The mislabeling extends the shelf life, potentially allowing use of expired devices.
Baxter Healthcare recalls Prismaflex HF Set devices due to a mistranslation in Estonian language instructions. The mistranslation contains contradictory information about patient body weight restrictions.
Hobbs Medical is recalling Cytology Brush Catalog Number 4206 due to incorrect expiration dates on product labels that extend the intended shelf life. Approximately 300 units were distributed nationwide and internationally between March 2018 and September 2020.
Hobbs Medical is recalling the Freeman Pancreatic Flexi-Stent Kit because the device label displays an incorrect expiration date that extends the shelf life. U.S. distribution of affected devices occurred between March 25, 2018 and September 28, 2020.
Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets with lot numbers ending in R due to incorrect expiration dates on device labels. Affected units were distributed worldwide from March 2018 to September 2020.
Novis PR, LLC recalled G-PREPROTEIN Liquid Dietary Supplement due to atypical bottle appearance, unusual odor, and atypical bubbles when opened. The recall affects 1,369 units distributed in Puerto Rico.
LUMINOSTICS recalled Clip COVID test kits because the manufacturer extended shelf life and expiration dates without FDA approval. The extended expiration dates lack FDA validation.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels. Affected units distributed in the US and internationally from 2018 to 2020 may have extended shelf lives beyond accuracy.
Hobbs Medical Spray Catheter devices sold between March 2018 and September 2020 have incorrect expiration dates on their labels. The error may extend the device's shelf life beyond its actual expiration.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices distributed between March 2018 and September 2020 due to incorrect expiration dates on product labels. The mislabeled devices display extended shelf-life information that does not reflect actual product safety.
Baxter Healthcare recalls the Prismaflex HF20 Set due to a mistranslation in device instructions that creates contradictory information about patient weight restrictions. The issue affects 29,764 devices distributed nationwide.
Renaissance Food Group is recalling its Small Ranch Tray with Dip due to positive test results for Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Mexican Style Layered Bean Dip (1.25 lb) distributed in Alabama, Georgia, and South Carolina due to positive test results for Listeria monocytogenes.
Arcade Industries candy corn sold at Shapiro Produce stores in Massachusetts and Connecticut is recalled due to undeclared egg allergen. People with egg allergies risk allergic reaction.
Renaissance Food Group is recalling 3 Skewer Veggie Kabobs due to confirmed Listeria monocytogenes contamination. Products were distributed in Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Mushroom Stir Fry Blend after testing detected Listeria monocytogenes in the finished product. Products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Large Mild Salsa (13 oz) due to positive Listeria monocytogenes test results. Products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Large Mild Chunky Guacamole (13 oz) due to positive test results for Listeria monocytogenes in the finished product.
Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.
Renaissance Food Group is recalling Fajita Mix due to positive test results for Listeria monocytogenes in the finished product. The recall affects products distributed in Alabama, Georgia, and South Carolina.
Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.
Renaissance Food Group is recalling Mango Habanero Blender (9 oz units) because positive test results detected Listeria monocytogenes in the finished product.
Renaissance Food Group is recalling Steak Topper seasoning (7.5 oz units) due to positive test results for Listeria monocytogenes. The affected product was distributed in Alabama, Georgia, and South Carolina.