FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 3 of 30

Class IIDeviceOngoing
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Merit Medical Systems, Inc. · South Jordan, UT
Class IIDeviceOngoing
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
Class IIDeviceOngoing
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Jenavalve Technology Inc. · Irvine, CA
Class IIDeviceOngoing
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Becton Dickinson & Co. · Sparks, MD
Class IIDeviceOngoing
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Howmedica Osteonics Corp. · Mahwah, NJ
Class IIDeviceOngoing
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Class IIDeviceOngoing
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific Corporation · Marlborough, MA
Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706; 6) CAROTID CDS-LF, Medline product number/SKU CDS983139B.
Class IIDeviceOngoing
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100. 4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000. 5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000. 6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000. 7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000.
Class IIDeviceOngoing
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Steris Corporation · Mentor, OH
Class IIFoodOngoing
QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life: 90 days. Type of packaging: Vacuum, resealable package. Net weight: 1.2 lbs. UPC: 094922980045.
Class IIFoodOngoing
Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27762 1
Saint Francis Apizza LLC · Cincinnati, OH
Class IIFoodOngoing
Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted barley flour), Dark Chocolate Chip (sugar, unsweetened chocolate, cocoa butter, soy lecithin, ground vanilla beans), Unsalted Butter, Dark Brown Sugar, Wheat flour, Eggs, Salt, Baking Powder, Baking Soda, Veribest Pastry flour (Wheat Flour); Contains: Milk, Wheat, Eggs; JK Patisserie & Bakery LLC DBA Le Petit Paris
Class IFoodOngoing
X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian Industry; Distributed by Natur Fuel, 2725 Armstrong Avenue, Clermont, FL 34714.
Class IFoodOngoing
LEASA Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 6 OZ. (170g); Grown & Packaged by: LEASA Industries Co., Inc., Mami FL 33147; Product of USA; UPC: 0 75465 11111 0
Class IIFoodCompleted
WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container with clear plastic lid. Net Wt. 54oz. UPC 2 67173 510983. WinCo Foods Salsa Bean Dip Tray 16inch (sold by catering special order only) is packaged in plastic tray container with clear plastic dome lid. Net Wt. 104oz. UPC 2 67240 ######. Both products sold refrigerated with a shelf life of 4 days from package date. Distributed by WinCo Foods 650 N. Armstrong Place Boise, ID.
Class IIFoodOngoing
Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted barley flour), Veribest Pastry flour (Wheat Flour), Unsalted Butter, Milk, Water, Granulated Sugar, Yeast, Salt, eggs; Contains: Wheat, Milk
Class IIFoodOngoing
Saint Francis Apizza Frozen Cheese Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27759 1
Saint Francis Apizza LLC · Cincinnati, OH
Class IIFoodOngoing
Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY, CA 94503 PRODUCT OF GREECE UPC: 073214003280
G L Mezzetta Inc · American Canyon, CA
Not Yet ClassifiedFoodOngoing
SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS Item 6516
Sierra Nevada Cheese Company, Inc · Willows, CA
Class IFoodOngoing
Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine, MADE IN ITALY, NET WT 22 OZ, BEST if Used By: SEP 21 2027 L6081A, UPC 194346442706, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PRODUCT OF ITALY
Class IFoodOngoing
Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton containing 5 individually wrapped packages of two donuts each. UPC: 850041392103. The Better Bakehouse Snack Co. 3651 Lindell Rd, Suite D700 Las Vegas, NV 89103
Class IFoodOngoing
Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb., 1/2 lb., 1 lb., and 5 lb. resealable bags and 50 lb. woven poly bags
Berlin Seeds · Millersburg, OH
Class IIFoodOngoing
Saint Francis Apizza Frozen Supreme Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27760 7
Saint Francis Apizza LLC · Cincinnati, OH
Class IFoodOngoing
biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIANA; Distributed by: Biofel
Class IIFoodOngoing
Lemon Blueberry Loaf packaged in a cardboard box; Ingredients: King midas flour, Veribest pastry flour, Granulated Sugar, Blueberries frozen IQF, Milk, Canola Oil, Eggs, Lemon Juice, Lemon Zest, Baking Powder, Lemon Extract, Salt; Contains: Wheat, Milk, Eggs
Class IFoodOngoing
LEASA Living Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 4 OZ. (113g); Grown & Packaged by: LEASA Industries Co., Inc., Mami FL 33147; Product of USA; UPC: 0 75465 55912 7
Class IIFoodOngoing
Saint Francis Apizza Frozen Mushroom & Onion Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27764 5
Saint Francis Apizza LLC · Cincinnati, OH
Class IIFoodOngoing
28 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero.
Pepsico Inc · Purchase, NY
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Reported Oct 21, 2026 · Z-0187-2027

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0168-2027

Medline Industries, LP · Northfield, IL

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Reported Oct 21, 2026 · Z-0180-2027

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Reported Oct 21, 2026 · Z-0134-2027

Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

Reported Oct 21, 2026 · Z-0140-2027

Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.

Reported Oct 21, 2026 · Z-0167-2027

BioFire Diagnostics, LLC · Salt Lake City, UT

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Reported Oct 21, 2026 · Z-0148-2027

Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.

Reported Oct 21, 2026 · Z-0143-2027

Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0173-2027

Neuronetics, Inc. · Malvern, PA

Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Reported Oct 21, 2026 · Z-0142-2027

If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

Reported Oct 21, 2026 · Z-0155-2027

QUESO PALMITA GP LLC · Stafford, TX

Undeclared milk, cheese declared

Reported Oct 14, 2026 · H-0015-2027

Undeclared soy allergen: soybean oil and soy lecithin

Reported Oct 14, 2026 · H-0021-2027

J K Patisserie & Bakery LLC · Long Island City, NY

Soy was not declared in the Contains statement.

Reported Oct 14, 2026 · H-0026-2027

A&P CREATIONS · Clermont, FL

Product contains undeclared Sildenafil and Tadalafil.

Reported Oct 14, 2026 · H-0016-2027

LEASA Industries Co., Inc. · Miami, FL

Seeds may have been contaminated with E.coli

Reported Oct 14, 2026 · H-0003-2027

WinCo Foods LLC · Boise, ID

Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue.

Reported Oct 14, 2026 · H-0008-2027

J K Patisserie & Bakery LLC · Long Island City, NY

Egg was not declared in the Contains statement.

Reported Oct 14, 2026 · H-0027-2027

Undeclared soy allergen: soybean oil and soy lecithin

Reported Oct 14, 2026 · H-0022-2027

Potential contamination with foreign objects: mice.

Reported Oct 14, 2026 · H-0007-2027

Potential contamination due to E. coli O26:H11.

Reported Oct 14, 2026 · N/A

GIAS FOOD INC. · New York, NY

Contamination with Listeria monocytogenes

Reported Oct 14, 2026 · H-0014-2027

The Better Bakehouse Snack Company · Las Vegas, NV

Undeclared Milk.

Reported Oct 14, 2026 · H-0011-2027

Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination.

Reported Oct 14, 2026 · H-0013-2027

Undeclared soy allergen: soybean oil and soy lecithin

Reported Oct 14, 2026 · H-0024-2027

A&P CREATIONS · Clermont, FL

Product contains undeclared Sildenafil and Tadalafil.

Reported Oct 14, 2026 · H-0017-2027

J K Patisserie & Bakery LLC · Long Island City, NY

Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement.

Reported Oct 14, 2026 · H-0025-2027

LEASA Industries Co., Inc. · Miami, FL

Seeds may have been contaminated with E. coli

Reported Oct 14, 2026 · H-0002-2027

Undeclared soy allergen: soybean oil and soy lecithin

Reported Oct 14, 2026 · H-0023-2027

Undeclared Yellow No. 6 and/or Yellow No. 5

Reported Oct 14, 2026 · H-0009-2027