The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

11576–11600 of 27206

  • 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
  • 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 (Devices)·Z-1724-2024·2024-05-08

    Zimmer ZPLP Fibular Plate May Fail to Lock Properly During Surgery

    The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
    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-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-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 (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-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
  • 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 (Food)·F-1206-2024·2024-05-08

    Longreen Corporation Reishi Coffee recalled for undeclared soy and coconut allergens

    BF Suma Pharmaceuticals is recalling Longreen Corporation 4 in1 Reishi Coffee because soy lecithin and coconut oil were not declared on the label. Consumers with soy or coconut allergies could have allergic reactions.

    Product
    Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet, 10 sachets/box
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1691-2024·2024-05-08

    Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram

    Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.

    Product
    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1749-2024·2024-05-08

    Radiation therapy planning system doses may be calculated incorrectly

    Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.

    Product
    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
    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-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-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-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-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-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-1731-2024·2024-05-08

    Medtronic Invos Infant Sensor Cables recalled for manufacturing defects

    Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.

    Product
    Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
    Category
    Medical Device
    Distribution
    25 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 (Food)·F-1212-2024·2024-05-08

    Food Club All Purpose Flour recalled for undeclared allergens

    Shawnee Milling Company recalled 3,360 bags of 5 lb. Food Club All Purpose Flour due to undeclared milk, egg, and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    5 lb.Food Club All Purpose Flour Best if Used by 03/08/2025
    Category
    Food
    Distribution
    0 states
  • 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-1729-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect

    Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0477-2024·2024-05-08

    Methylergonovine Maleate tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
    Category
    Drug
    Distribution
    Distributed nationwide