The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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15876–15900 of 27762

  • HighFDA (Devices)·Z-0081-2024·2023-10-18

    Infusion pump component force sensor may malfunction or trigger false alarms

    Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.

    Product
    Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2024·2023-10-18

    Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging

    Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2024·2023-10-18

    Cardinal Health procedure packs recalled for containing previously recalled components

    Cardinal Health is recalling surgical procedure packs that contain previously recalled components including equipment drapes, table covers, and surgical room turnover kits. Approximately 13,351 packs were distributed nationwide and in Canada.

    Product
    Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2024·2023-10-18

    EMPOWR hip acetabular implant packaging incorrectly contains knee implant component

    Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.

    Product
    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2024·2023-10-18

    FDA Recalls Zemits NDPrime Yag Laser for Missing Safety Interlocks

    Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.

    Product
    MED-810A Zemits NDPrime Laser products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2024·2023-10-18

    Constellation Vision System surgical units recalled for pressure control defect

    Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.

    Product
    Constellation Vision System, REF: 8065751150
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0093-2024·2023-10-18

    BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

    Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

    Product
    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2024·2023-10-18

    Medical Procedure Packs Recalled Due to Defective Components

    Cardinal Health is recalling surgical procedure packs due to defective components. The recall affects 13,351 packs distributed across the US and Canada.

    Product
    Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0008-2024·2023-10-18

    LittleOak Goat Milk Infant Formula Recalled for Mixing Instructions Not in Ounces

    LittleOak Natural Goat Milk Infant Formula (Stage 1) is recalled due to mixing instructions not provided in ounces and lack of pre-market FDA notification. About 14,100 cans distributed nationwide are affected.

    Product
    LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-0096-2024·2023-10-18

    GAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches

    Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.

    Product
    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2024·2023-10-18

    Surgical instrument button malfunction may extend operative time

    Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.

    Product
    THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2024·2023-10-18

    Surgical gloves recalled for incomplete sterile pouch sealing

    Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.

    Product
    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2024·2023-10-18

    Olympus THUNDERBEAT surgical instrument blue seal button may fail to return to neutral

    Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.

    Product
    THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nisse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2024·2023-10-18

    Immunoassay Analyzer Software Error May Cause Sample Result Mix-up

    The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.

    Product
    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0009-2024·2023-10-18

    LittleOak Infant Formula Recalled for Missing FDA Approval and Incorrect Mixing Instructions

    The Little Oak Company is recalling LittleOak Natural Goat Milk Follow On Infant Formula Stage 2 due to lack of FDA pre-market notification and mixing instructions not provided in ounces.

    Product
    LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs) tin cans - six cans per case.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-0078-2024·2023-10-18

    Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms

    Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.

    Product
    Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2024·2023-10-18

    Reverse Shoulder Prosthesis Screws May Have Incorrect Size

    Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.

    Product
    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0082-2024·2023-10-18

    RoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization

    RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.

    Product
    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0010-2024·2023-10-18

    Markside Peanut Butter Chocolate Cake Recalled for Undeclared Peanut Allergen

    Fairfield Gourmet Food Corp is recalling Markside Ultimate Peanut Butter Chocolate Cake (LOT #BS23212) due to mislabeled peanut allergen. Consumers with peanut allergies should not consume the product.

    Product
    Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g), plastic package (i.e.) Clamp shell, 8 package per case, Frozen master case (keep refrigerator Retail pack. LOT # BS23212 (Manufactured on July, 31, 2023).
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0012-2024·2023-10-18

    Maisie Jane's Smooth Almond Butter Recalled for High Aflatoxin Levels

    Maisie Jane's Smooth almond butter is being recalled due to high levels of aflatoxin contamination. Consumers should discard the product or return it for a refund.

    Product
    Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units per case, shelf stable
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide