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.
Taylor Farms Colorado is recalling raw yellow onions distributed to food service facilities in six states due to potential E. coli O157:H7 contamination. Use-through dates range from October 16 to November 3, 2024.
Taylor Farms Colorado is recalling raw yellow onions due to potential E. coli O157:H7 contamination distributed to food service facilities in CO, KS, MO, NE, NM, and UT.
FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.
Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.
Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.
Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.
Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.
Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.
ImperialFresh processed fajita peppers made by FreshPoint Denver, Incorporated have been recalled due to potential E. coli O157:H7 contamination. Seven cases distributed in Colorado are affected.
IMPERIALFRESH processed yellow onions are being recalled due to potential E. coli O157:H7 contamination. Products were distributed in Colorado and produced October 8-22, 2024.
Taylor Farms Colorado is recalling 615 cases of raw yellow onions for potential E. coli O157:H7 contamination. Affected food service facilities are in CO, KS, MO, NE, NM, and UT.
Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.
Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.
AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.
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 angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.
Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
AVID Medical is recalling Halyard RAD PACK medical convenience kits containing sponge forceps and towel clamps. Small metal flakes may detach and enter surgical sites, potentially causing foreign body or local tissue reactions.
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.