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 1 of 30

Class IIFoodOngoing
Stewarts Shops Vanilla Heavenly Medley 1/2 Gallon (1.89 L), UPC Codes: 0 82086 44371 1
Stewart's Shops Corp. · Saratoga Springs, NY

Foreign object: May contain pieces of metal

Reported Oct 21, 2026 · H-0094-2027

Class IIFoodOngoing
J. HIGGS Loaded Bacon & Cheddar Potato Chips, NET WT 7.75 OZ (219.7g) bag, UPC 051933316454. Sold as 13 (7.75oz) bags per case.
Saratoga Potato Chips LLC · Fort Wayne, IN

Undeclared soy.

Reported Oct 21, 2026 · H-0090-2027

Class IIIFoodOngoing
Pur Aqua Sparkling Frost Cherry Limeade 17 oz., UPC: 4099100167023
Refresco Beverages US Inc · Tampa, FL

May contain undeclared aspartame.

Reported Oct 21, 2026 · H-0095-2027

Class IFoodOngoing
Made Fresh brand Black Bean and Corn Salad; 5lb white plastic tub
Made Fresh Salads Inc · Bay Shore, NY

Products may be contaminated with Listeria monocytogenes.

Reported Oct 21, 2026

Class IIFoodOngoing
Made From Plants; Daring; Plant Steak Bites; Ready in 4 Mins Microwaveable Pouch; UPC: 86001124319
DARING FOODS INC · Long Beach, CA

defective packaging; packaging can rupture/explode during cooking.

Reported Oct 21, 2026 · H-0091-2027

Class IIFoodOngoing
Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon (1.89 L), UPC: 0 82086 44377 3
Stewart's Shops Corp. · Saratoga Springs, NY

Foreign object: May contain pieces of metal

Reported Oct 21, 2026 · H-0093-2027

Class IIFoodOngoing
Holsum Spinach Flour Tortillas Large, 8 count (20 oz.) UPC: 810023430629
Holsum De Puerto Rico, Inc. · Toa Baja, PR

Undeclared colors (FD&C Blue No. 1 and FD&C Yellow No. 5)

Reported Oct 21, 2026 · H-0089-2027

Class IFoodOngoing
Deano's Pasta; Pear and Pecorino Triangoli Ravioli, 1lb.; Ingredients: Dough: Semolina (Wheat, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Water, Fresh Eggs, Salt. Filling: Pears, Ricotta (Whey, Cream, Milk), Pecorino Cheese (Milk, Cultures, Salt, Enzymes), Breadcrumbs (Wheat Flour, Cane Sugar, Yeast, Salt), Brandy, Dark Brown Sugar, Salt, Black Pepper.; CONTAINS: WHEAT, MILK, EGG ingredients; MAY CONTAIN OTHER ALLERGENS; KEEP FROZEN
DEANO'S PASTA · Somerville, MA

Undeclared Lobster

Reported Oct 21, 2026 · H-0092-2027

Class IIDrugOngoing
Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Houston Rx LLC · Houston, TX

Lack of process control

Reported Oct 21, 2026 · D-0041-2027

Class IIDrugOngoing
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05
Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Presence of Foreign Tablets/Capsules

Reported Oct 21, 2026 · D-0038-2027

Class IIDrugOngoing
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11
American Health Packaging · Columbus, OH

Presence of Foreign Tablets/Capsules

Reported Oct 21, 2026 · D-0042-2027

Class IIDrugOngoing
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.
Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Failed Impurities/Degradation Specifications.

Reported Oct 21, 2026 · D-0039-2027

Class IIDrugOngoing
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Houston Rx LLC · Houston, TX

Lack of assurance of sterility.

Reported Oct 21, 2026 · D-0040-2027

Class IIDeviceOngoing
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Howmedica Osteonics Corp. · Mahwah, NJ

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-0164-2027

Class IIDeviceOngoing
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Ferno-Washington Inc · Wilmington, OH

Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.

Reported Oct 21, 2026 · Z-0145-2027

Class IIDeviceOngoing
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics Corp. · Mahwah, NJ

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-0166-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;
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-0176-2027

Class IDeviceOngoing
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory · Bedford, MA

Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Reported Oct 21, 2026 · Z-0002-2027

Class IIDeviceOngoing
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112
Cook Incorporated · Bloomington, IN

The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.

Reported Oct 21, 2026 · Z-0163-2027

Class IIDeviceOngoing
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are produced from a fiber form of DBM Crunch" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.
Medtronic Sofamor Danek USA Inc · Memphis, TN

Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.

Reported Oct 21, 2026 · Z-0138-2027

Class IIDeviceOngoing
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Medline Industries, LP · Northfield, IL

Discrepancy in the shelf-life of a component

Reported Oct 21, 2026 · Z-0189-2027

Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
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-0184-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
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-0178-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
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-0172-2027

Class IIIDeviceOngoing
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics, Inc. · North Billerica, MA

In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

Reported Oct 21, 2026 · Z-0162-2027

Class IIDeviceOngoing
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description: LIKORALL 242 ES, WHITE Product Code: 3122006NA Product Description: LIKORALL 242 ES, WHITE Product Code: 3122007 Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122007NA Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122008 Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122008NA Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122009 Product Description: LIKORALL 242 S, NATURAL Product Code: 3122009NA Product Description: LIKORALL 242 S, NATURAL Product Code: 3122010 Product Description: LIKORALL 242 S, WHITE Product Code: 3122011 Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122011NA Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122012 Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122012NA Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122501 Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122501NA Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122502 Product Description: LIKORALL 250 ES, WHITE Product Code: 3122502NA Product Description: LIKORALL 250 ES, WHITE Product Code: 3123001 Product Description: LIKORALL 243 ES Product Code: 3123001NA Product Description: LIKORALL 243 ES Product Code: 3123002 Product Description: LIKORALL 243 ES, WHITE Product Code: 3123002NA Product Description: LIKORALL 243 ES, WHITE Product Code: 3124050 Product Description: LIKORALL 250 S, IRC
Baxter Healthcare Corporation · Deerfield, IL

Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

Reported Oct 21, 2026 · Z-0151-2027

Class IIDeviceOngoing
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Beckman Coulter, Inc. · Miami, FL

The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.

Reported Oct 21, 2026 · Z-0160-2027

Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258A KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116D DYKMBNDL116F ROBOTIC GYN DYNJ907827F ROBOTIC PACK DYNJ50474G RR-DAVINCI PROSTATE ACCESSORY DYNJ63392C DYNJ63392F
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-0183-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.
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-0177-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU DYNJ0362405S; 10) OPEN HEART, Medline product number/SKU DYNJ907676I; 11) FEM POP MARYVIEW, Medline product number/SKU DYNJ911714; 12) CABG PACK, Medline product number/SKU DYNJ906346G; 13) DEBOER HEART MAIN, Medline product number/SKU DYNJ907914I; 14) OPEN HEART A & B PACK, Medline product number/SKU DYNJ9718008AU; 15) OPEN HEART, Medline product number/SKU DYNJ911483A; 16) CABG ACCESSORY PACK, Medline product number/SKU DYNJ59265; 17) HEART, Medline product number/SKU DYNJ908779B; 18) CARDIOVASCULAR PACK, Medline product number/SKU DYNJ69507F; 19) OFF PUMP CABG CDS, Medline product number/SKU CDS840087AN; 20) PACK CABG CHRG, Medline product number/SKU DYNJ905683D; 21) HEART CDS, Medline product number/SKU CDS840179N;
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-0170-2027

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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.