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.
Boar's Head Smoked Gouda in 8 oz packages is being recalled because of mislabeling. 65 cases are affected, distributed in Florida.
Pasteurized Donor Human Milk in 4 oz bottles is being recalled because plastic particulate from the outer closure was found between the foil seal and the plastic cap. 209 bottles are affected.
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent is being recalled because of CGMP deviations. 21,265 cases are affected.
LION Mixed Berry Spring Water Hydration Drink in 20 fl oz bottles is being recalled because of potential contamination with floating objects. 43 cases are affected.
Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant is being recalled because of CGMP deviations. 23,467 cases are affected.
LION Pineapple Spring Water Hydration Drink in 20 fl oz bottles is being recalled because of potential contamination with floating objects. 41 cases are affected.
Two bags of compounded Peripheral Parenteral Nutrition are being recalled because a daily cleaning step in the ISO-5 compounding area was not sufficiently documented.
LION Lemon Lime Spring Water Hydration Drink in 20 fl oz bottles is being recalled because of potential contamination with floating objects. 58 cases are affected.
NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.
KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.
Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.
LION Watermelon Spring Water Hydration Drink in 20 fl oz bottles is being recalled because of potential contamination with floating objects. 48 cases are affected.
New Mexico Pinon Coffee Dark Pinon Single Serve cups are being recalled because an inconsistent clear coat seal allows the food safe ink printing to run in a K-cup machine. 154 units affected.
Compounded Testosterone 200 mg Pellet in 1 mL amber vials is being recalled because a printing issue resulted in incorrect lot numbers on the label. 2,832 vials are affected.
The Hillrom Q-Link 13 component used with mobile patient lifts is being recalled because it may allow false latching of the quick-release hook. 9,899 units are affected.
Whole Organic Celery Seed is being recalled because of potential contamination with Salmonella. 439 bags totalling 24,694 lbs are affected.
Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.
Hillrom LikoScale components used with patient lift adapter kits are being recalled because the Q-link 13 may allow false latching of the quick-release hook. 9,839 units are affected.
Weaver Chocolates Nonpareil Semi-Sweet Chocolate in 25 lb bulk cases is being recalled because of an undeclared milk allergen. 849 cases are affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018AS, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 558 units affected.
Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.
The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.