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.
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.
Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.
Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in loss of speaker output.
Joy Gourmet Foods LLC is recalling Joy Sweet Lassi 16 oz. bottles due to inadequate pasteurization. The product was distributed in NY, NJ, and PA with expiry dates from June 30 through July 30, 2026.
Champion Foods, LLC is recalling Motor City Pizza Co. 5 Cheese Bread due to potential salmonella contamination. Affected products were distributed nationwide at major retailers.
SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.
SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.
Pearl Milling Company Original Pancake & Waffle Mix Complete (5.99 oz) is being recalled because it contains undeclared milk and soy allergens. The product was distributed only in Puerto Rico.
Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.
Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.
Stryker Neurovascular is recalling the INZONE Detachment System (REF: M00345100950) due to premature battery drain that may prevent the device from powering on or detaching coils as intended.
Joy Peach Lassi 16 oz. is being recalled because the product was not adequately pasteurized, which may allow harmful bacteria to survive.
Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.
Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.
Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.
Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.
Joy Gourmet Foods LLC is recalling Joy Mint Lassi 16 oz. because the product was not adequately pasteurized, which may allow harmful bacteria to survive.
TMJ Solutions Inc is recalling TMJ Bilateral Implants (REF: CHG020) because some units may contain incorrect patient-specific components, causing poor implant fit and right-sided open bite.
Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.
Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.
Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.