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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13801–13825 of 31490

  • HighFDA (Devices)·Z-1752-2024·2024-05-08

    RayStation radiation therapy system dosing parameter recall

    RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.

    Product
    RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2024·2024-05-08

    OsmoPRO MAX Clinical Osmometer Recall for Software Errors and Result Inaccuracy

    Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.

    Product
    OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2024·2024-05-08

    RayStation radiation therapy planning system may report inaccurate dosimetry values

    RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.

    Product
    RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2024·2024-05-08

    Medtronic Invos Sensor Cable Recalled for Manufacturing Defects

    Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.

    Product
    Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1722-2024·2024-05-08

    Zimmer surgical fracture plates may fail to lock properly

    Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2024·2024-05-08

    Olympus POWERSEAL Surgical Sealer Recalled for Non-Functional Seal Activation

    Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.

    Product
    POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2024·2024-05-08

    POWERSEAL surgical sealer malfunction causes incomplete seal cycle

    Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.

    Product
    POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2024·2024-05-08

    Zimmer Periarticular Locking Plate May Fail to Secure Fracture Fixation

    Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2024·2024-05-08

    Lumbar Interbody Fusion Curette Recalled for Potential Blade Shearing

    Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.

    Product
    ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2024·2024-05-08

    Radiation therapy planning system dose calculation error

    RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.

    Product
    RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2024·2024-05-08

    Zirconium oxide dental restoration blocks may develop cracks during sintering

    IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.

    Product
    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1214-2024·2024-05-08

    French's Crispy Fried Onions Recalled for Potential Staphylococcus aureus Growth

    McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product (UPC: 041500959030, July 23, 2025) was distributed in Arizona and Illinois.

    Product
    FRENCH S CRISPY FRIED ONIONS ORIG 240/26.5 OZ PDM
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1213-2024·2024-05-08

    French's Crispy Fried Onions Recalled for Potential Staphylococcus Growth

    McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product was distributed to consumers in Arizona and Illinois.

    Product
    FRENCH S CRISPY FRIED ONIONS ORIG 16/6 OZ, Case Pack - 16/6 OZ,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1719-2024·2024-05-08

    Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall

    Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2024·2024-05-08

    Zimmer Periarticular Locking Plate threading defect may compromise surgical fixation

    Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2024·2024-05-08

    Zimmer Fibular Plate Recall: Locking Hole Thread Form Defect

    Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Locking Screw Defect

    Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2024·2024-05-08

    RayStation radiation therapy planning software affected by source-to-surface distance calculation error

    RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.

    Product
    RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2024·2024-05-08

    ZPLP Distal Lateral Fibular Plates Recalled for Defective Threading

    Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2024·2024-05-08

    Battery Mobile X-ray Units Recalled for Anti-Fall System Interference

    SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.

    Product
    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2024·2024-05-08

    Sofsilk Braided Silk sutures recalled due to excess sterilization

    One lot of Sofsilk Braided Silk sutures (Product Number S-2782K) was exposed to more sterilization cycles than approved, which may reduce tensile strength and increase risks of wound complications and infections during surgery.

    Product
    Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1723-2024·2024-05-08

    ZPLP Distal Lateral Fibular Plates: locking screws may not secure

    Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2024·2024-05-08

    Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels

    Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.

    Product
    Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900
    Category
    Food
    Distribution
    0 states