The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11326–11350 of 53044

  • HighFDA (Devices)·Z-0079-2024·2023-10-18

    Medfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift

    Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.

    Product
    Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2024·2023-10-18

    Cardinal Health recalls Presource Fistulogram Packs with defective components

    Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.

    Product
    Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
    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-0105-2024·2023-10-18

    Multichem IA Plus and Controls Recalled Due to Broken Glass Vials

    TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus and related controls due to broken glass vials that may expose laboratory personnel to biohazardous material. Affected lots should be discontinued immediately.

    Product
    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2024·2023-10-18

    Access Thyroglobulin Calibrators Recalled for Inaccurate Test Results

    Beckman Coulter recalls Access Thyroglobulin Calibrators that cause approximately 11% decrease in patient test results. The recall affects about 5,980 units distributed worldwide except the US, Canada, and China.

    Product
    Access Thyroglobulin Calibrators
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0086-2024·2023-10-18

    Surgical procedure packs containing recalled equipment components distributed nationwide

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide that contain recalled components including equipment drapes and table covers.

    Product
    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit…
    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-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-0089-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs Due to Defective Components

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.

    Product
    Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5)…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-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…
    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-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 (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-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 (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
  • HighNHTSA·23V699000·2023-10-17

    Autocar recalls 2021 Legend and Xpeditor vehicles for parking brake warning malfunction

    Autocar is recalling 2021-2023 Legend and 2016-2023 Xpeditor vehicles because the parking brake warning light may illuminate incorrectly when air is lost from the system. Dealers will replace the pressure switch free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V696000·2023-10-17

    2023-2024 Alfa Romeo Tonale Pedestrian Alert Siren Disconnection Recall

    Chrysler is recalling 2023-2024 Alfa Romeo Tonale and Dodge Hornet plug-in hybrid vehicles because the pedestrian alert siren may be missing or disconnected. When non-functional, the siren cannot warn pedestrians of the vehicle backing up, increasing injury risk.

    Product
    ALFA ROMEO — ALFA ROMEO, DODGE TONALE PHEV, HORNET, TONALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V694000·2023-10-16

    Winnebago recreational vehicles recalled for unintended awning deployment

    Winnebago is recalling 2020-2024 Era, View, and Navion recreational vehicles because the retractable awning may extend unintentionally during transit, becoming a distraction or road hazard that could increase crash risk.

    Product
    WINNEBAGO — WINNEBAGO NAVION, VIEW, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide