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.
GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.
Houston Pecan Company is recalling blanched hazelnuts in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies to these ingredients should not consume the product.
Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.
Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.
Houston Pecan Company recalls Papaya Sweetened in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross contamination. Affected products were distributed in Texas and through internet sales.
Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.
Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.
Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.
Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.
The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.
Houston Pecan Company is recalling roasted peanuts purchased before May 25, 2023, for undeclared allergen cross-contamination with tree nuts, peanuts, and wheat. The products were sold in Texas and through internet sales.
Houston Pecan Company is recalling Black Mission Figs in 5-pound bags distributed in Texas and via internet due to undeclared tree nuts, peanuts, and wheat from allergen cross-contamination.
Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.
Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.
Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.
Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.
Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.
Central Admixture Pharmacy Services is recalling a neonatal IV nutrition bag due to lack of sterility assurance. The recall affects 156 bags of the product distributed nationwide.
Houston Pecan Company is recalling 5-pound bags of pumpkin seeds sold in Texas and online due to potential cross-contamination with undeclared tree nuts, peanuts, and wheat.
Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.