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.
U.S. Tov, Inc. is recalling Dragonfly Jelly Bar Handbags and Backpacks due to a potential choking hazard from konjac. The products were distributed nationwide.
Fresh Express Kit Salsa! Ensalada salad kits are recalled for potential Listeria monocytogenes contamination in the cheese condiment. The affected 12.1 oz bags were distributed to AL, FL, GA, CA, UT, WA, and Canada.
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
Byrne Dairy, Inc is recalling Mighty Fine Chocolate Ice Cream because it contains undeclared peanuts. Consumers with peanut allergies should not consume this product.
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
Hans Kissle Company is recalling Mexican Style Quinoa Salad due to undeclared soy and egg allergens. The product was distributed in the Northeast and may pose serious risk to consumers with allergies.
GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.
Utz Wavy Originals Potato Chips (2.75 oz) distributed in New York may contain undeclared milk and could pose a risk to people with milk allergies.
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.
Al Amir Fresh Foods Baba Ghannooj Grilled Eggplant is recalled for undeclared sesame. The product contains tahini but the label does not list sesame as an ingredient, posing a risk to consumers with sesame allergies.
Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.
Woodstock 5 Grain Cereal is recalled because triticale, a product ingredient, is not identified as wheat on the label. This creates a risk for people with wheat allergies.
CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.
The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.
Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.
Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.
BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.
Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.
BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.
OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.
The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.
IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.
Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.
Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.