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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12776–12800 of 27721

  • SevereFDA (Devices)·Z-1693-2024·2024-05-08

    Thoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak

    Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
    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-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 (Drugs)·D-0479-2024·2024-05-08

    EYLEA injection recalled for sterility concerns and syringe breakage complaints

    Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.

    Product
    EYLEA — EYLEA (AFLIBERCEPT)
    Category
    Drug
    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-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-1740-2024·2024-05-08

    Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination

    Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.

    Product
    The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2024·2024-05-08

    Zimmer Periarticular Locking Plates Recalled for Potential Loss of Surgical Fixation

    Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2024·2024-05-08

    Jackson-Pratt 3-Spring Reservoir Drain Kits Shipped Without Sterilization

    Cardinal Health is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits because they were shipped to users before sterilization. Unsterilized surgical drains pose an infection risk.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
    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-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-1755-2024·2024-05-08

    Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect

    Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.

    Product
    Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V587000·2024-05-08

    2023 International HV and MV Driveshaft Failure Recall

    Navistar recalls certain 2023 International HV and MV vehicles; driveshafts may break under certain conditions, causing loss of drive power and increasing crash risk. Replacement is free.

    Product
    INTERNATIONAL — 2023 INTERNATIONAL HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking

    A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1245-2024·2024-05-08

    International Bread Pita Chips Recalled for Undeclared Wheat Allergen

    International Bread Pita Chips are being recalled because the product label lists flour as an ingredient but fails to disclose that wheat is a sub-ingredient of the flour, a major allergen.

    Product
    International Bread Pita Chips Retail Clamshell Container: 10oz., Bulk bag: 10lbs. Garlic Baked Pita Chips: 6 81942 22111 3
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1704-2024·2024-05-08

    Zirconium oxide dental blocks recalled due to cracking risk

    IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2024·2024-05-08

    Philips Spectral CT Oncology Imaging System Recall: Laser Reflection Hazard

    Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.

    Product
    The Oncology Essentials Package of the Spectral CT imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2024·2024-05-08

    Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments

    Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.

    Product
    Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2024·2024-05-08

    Zirconium oxide dental blocks recalled for cracking risk

    IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.

    Product
    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2024·2024-05-08

    Hip Cup Removal Instrument Recalled Due to Wrong Blade Assembly

    Innomed is recalling the Cup Removal Starter Instrument due to a manufacturing error where the finisher blade was affixed instead of the starter blade. The wrong blade could compromise surgical performance during hip replacement procedures.

    Product
    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
    Category
    Medical Device
    Distribution
    11 states
  • 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-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 (Drugs)·D-0476-2024·2024-05-08

    FDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops

    The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.

    Product
    Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2024·2024-05-08

    Jackson-Pratt 3-Spring Reservoir Kit Recalled Due to Non-Sterile Shipment

    Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
    Category
    Medical Device
    Distribution
    Distributed nationwide