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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

6926–6950 of 27393

  • SevereFDA (Devices)·Z-0094-2024·2023-10-25

    Sapphire Infusion Pumps recalled for software air-detection failure

    Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.

    Product
    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2024·2023-10-25

    Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications

    Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.

    Product
    Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2024·2023-10-25

    HydroPICC Catheter Kit Recalled for Missing Safety Warnings

    Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.

    Product
    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2024·2023-10-25

    Surgical Instrument Shears Recalled Due to Incomplete Packaging Seal

    MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.

    Product
    MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0122-2024·2023-10-25

    Functional MRI Software Bug May Cause DICOM Export Data Mismatch

    A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

    Product
    Functional MR V1.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0125-2024·2023-10-25

    Wrist and Thumb Orthosis Recalled for Undeclared Latex

    North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.

    Product
    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0112-2024·2023-10-25

    Monoject tuberculin syringes incompatible with certain IV connectors

    Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.

    Product
    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0114-2024·2023-10-25

    HydroPICC Catheter Kit Recall: Missing Critical Use-Restriction Warnings

    Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.

    Product
    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2024·2023-10-25

    DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip

    DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.

    Product
    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2024·2023-10-18

    Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk

    Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.

    Product
    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2024·2023-10-18

    Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching

    Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.

    Product
    2008T GEN 2 Bibag without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2024·2023-10-18

    10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage

    Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.

    Product
    10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0030-2024·2023-10-18

    2008T Hemodialysis System recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.

    Product
    2008T Hemodialysis System w/Bibag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2024·2023-10-18

    FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material

    Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.

    Product
    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0029-2024·2023-10-18

    Hemodialysis machines recalled for potential printed circuit board contamination

    Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.

    Product
    2008T Hemodialysis System without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0035-2024·2023-10-18

    Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.

    Product
    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0033-2024·2023-10-18

    Hemodialysis machines recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.

    Product
    2008T HD SYS. CDX W/BIBAG BLUESTAR
    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-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-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-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