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.

9026–9050 of 53036

  • 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 (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-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-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 (Food)·F-1211-2024·2024-05-08

    Johnny's Parmesan Garlic Seasoning recalled for undeclared sesame allergen

    Johnny's Parmesan Garlic Seasoning contains undeclared sesame seeds that are visible through the bottle but not listed on the label. The product may pose a risk to consumers with sesame allergies.

    Product
    Bottle is labeled as Johnny's Parmesan Garlic Seasoning, 5oz (141g), packaged in poly bottle with green spice cap, UPC 0 70381 10060 6. Distributed by Johnny s Fine Foods Inc. 319 E. 25th St. Tacoma, WA 98421. Label declares: CONTAINS: MILK. MANUFACTURED IN A FACILITY THAT ALSO
    Category
    Food
    Distribution
    9 states
  • 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-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-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-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 (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
  • HighFDA (Food)·F-1244-2024·2024-05-08

    International Bread Pita Chips Recalled for Undeclared Wheat Allergen

    International Bread Pita Chips are recalled because the label declares flour as an ingredient but does not identify wheat as a sub-ingredient. This poses a risk to consumers with wheat allergies.

    Product
    International Bread Pita Chips Retail Clamshell Container: 10oz., Bulk bag: 10lbs. UPC: Plain Baked Pita Chips: 6 81942 22110 6
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1208-2024·2024-05-08

    Coffee Product Recalled for Undeclared Soy and Coconut Allergens

    BF Suma Pharmaceuticals is recalling Longreen Corporation Xlim Express Coffee due to undeclared soy lecithin and coconut oil. The product was distributed to California, Texas, Canada, and Guatemala.

    Product
    Longreen Corporation Xlim Express Coffee, 15 grams/sachet, 10 sachets/box
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1741-2024·2024-05-08

    RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error

    RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.

    Product
    RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2024·2024-05-08

    Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly

    RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.

    Product
    RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. 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-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-1734-2024·2024-05-08

    Galaxy System Wired Controller Recalled for Unintended Scope Motion

    Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.

    Product
    Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    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-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-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-1709-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate may fail to lock screws securely

    Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2024·2024-05-08

    RayStation Radiation Therapy System Recalled for Potential Dosing Error

    RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.

    Product
    RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
    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-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