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.
AVID Medical is recalling Halyard KIT, TOTAL KNEE medical convenience kits due to loose metal flakes in sponge forceps and towel clamps that could contaminate surgical sites.
Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.
AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical recalled Halyard POST PARTUM TUBAL LIGATION surgical kit components due to loose metal flakes that could detach from sponge forceps and towel clamps. Metal flakes entering a patient's surgical site could cause local or foreign body reactions.
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.
Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.
AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.
AVID Medical is recalling Halyard Pacemaker Pack surgical kits because sponge forceps and towel clamps contain loose metal flakes that could detach and enter patient surgical sites.
AVID Medical recalls Halyard Knee Arthroscopy Packs due to loose metal flakes that could detach from forceps and clamps. Metal fragments may enter the surgical site, potentially causing local or foreign body reactions.
The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.
Westby Cooperative Creamery is recalling Westby Pepper Cheese Curds due to potential E. coli contamination. The affected 12-ounce packages with expiration date 11-26-24 were distributed in Wisconsin.
AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.
The Kroger Co is recalling Home Chef Asian Style Chicken Stir Fry due to potential contamination with Listeria monocytogenes. The recall affects 31,424 consumer units distributed across the United States.
AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.
AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.