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.
UIH Technologies is recalling two uEXPLORER PET/CT systems because third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference.
Sedecal is recalling 10 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
UIH Technologies is recalling 95 uMI 550 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg across several lots after routine stability testing returned an out-of-specification result for highest unknown impurity.
Home Health US is recalling 4,661 One Step Sterile Lancets because of incorrect or missing Unique Device Identifier codes.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-P190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
IntegraDose Compounding Services is recalling 853 bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride after testing revealed there was no oxytocin in the IV bag.
Boston Scientific is recalling 3,592 PROPONENT DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Wholesale Produce Supply is recalling cut fresh fruit mix under several brands and sizes for potential Listeria monocytogenes contamination.
Vicky IT is recalling 10 lbs of Bona Fish because the fish is un-eviscerated and may be contaminated with Clostridium botulinum, is contaminated with mold, and contains insect larvae.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-H190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Black Sheep Egg Company is recalling 23,625 dozen Free Range Grade A Large Brown Eggs in 12-count cartons for potential Salmonella contamination.
Boston Scientific is recalling 12,326 VISIONIST CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Black Sheep Egg Company is recalling 7,200 dozen Free Range Grade AA Large White Eggs sold loose on open skids for potential Salmonella contamination.
Boston Scientific is recalling 4,055 ALTRUA 2 DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Garden Fresh Foods is recalling 540 lbs of sliced green onions after the firm tested one lot in-house and found Listeria monocytogenes.
Boston Scientific is recalling 1,380 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Wholesale Produce Supply is recalling Cut Fresh Cantaloupe Chunks in several container sizes under the Fresh & Finest and Harvest Cuts brands for potential Listeria monocytogenes contamination.
Boston Scientific is recalling 3,620 VALITUDE CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling Bronchofiberscope BF Type PE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA Bronchovideoscope BF Type XT160 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 32,695 ACCOLADE DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Wholesale Produce Supply is recalling cut fresh melon mix under several brands and sizes for potential Listeria monocytogenes contamination.
Olympus is recalling Bronchovideoscope BF-XT190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.