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.
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.
Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).
BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.
Amerisource Health Services is recalling Duloxetine Delayed-Release Capsules 60 mg due to N-nitroso impurity levels exceeding FDA recommended limits. The recall affects 20,734 bottles distributed nationwide.
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
Crab Cheese Rangoon frozen appetizers manufactured by SE Tampa Inc are recalled due to undeclared allergens: milk, soy, shellfish, and fish. Consumers with these allergies should not consume the product.
Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.
Whole Foods Market Organic Carrot Sticks potentially contaminated with E. coli O121:H19 are being recalled. The recall affects 407 cases distributed in AZ, CA, HI, ID, and NV.
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.