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.

12151–12175 of 22152

  • HighFDA (Devices)·Z-1289-2024·2024-03-20

    STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk

    Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.

    Product
    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1057-2024·2024-03-20

    CK Egg Salad Sandwich Recall for Potential Sesame Cross-Contact

    Capitol Commissary LLC recalled CK Egg Salad Sandwich due to potential sesame cross-contact. Affected units were distributed in seven western U.S. states; consumers should not eat the product.

    Product
    CK Egg Salad Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983644000097.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1059-2024·2024-03-20

    Ready-to-Eat Chicken Salad Sandwich Recalled for Potential Sesame Cross-Contact

    Capitol Commissary LLC is recalling CK Chicken Salad On A Croissant due to potential cross-contact with sesame. The recall affects 29 units distributed across seven Western states.

    Product
    CK Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983644100032.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1058-2024·2024-03-20

    Jacksons Egg Salad sandwiches recalled for potential sesame allergen cross contact

    Capitol Commissary LLC is recalling 1,195 units of Jacksons Egg Salad sandwiches due to potential cross contact with sesame. Consumers with sesame allergies should not consume the affected product.

    Product
    Jacksons Egg Salad, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642540991.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0377-2024·2024-03-20

    Eye Drops Recall: TRP Eye Twitching Relief Lacks Sterility Assurance

    TRP Eye Twitching Relief sterile eye drops are being recalled nationwide because the manufacturer cannot assure the product meets sterility requirements. The affected lot (C303, expiring 07-27-2025) was distributed in the USA.

    Product
    TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·24161·2024-03-14

    U.S. Boiler Company Recalls Gas-Fired Residential Boilers for Carbon Monoxide Hazard

    About 2,500 U.S. Boiler, New Yorker Boiler, Advantage, FORCE, and Archer brand gas-fired boilers are recalled because the blocked vent switch can fail at altitudes above 5,400 feet, allowing carbon monoxide to accumulate in homes. No injuries have been reported.

    Product
    U.S. Boiler, New Yorker Boiler, Advantage, FORCE and Archer brand gas-fired hot water residential boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24159·2024-03-14

    Insignia Air Fryers and Ovens Recalled for Fire and Burn Hazards

    Best Buy is recalling about 187,400 Insignia brand air fryers and air fryer ovens sold from November 2021 through November 2023 because the units can overheat, causing handles to melt, glass doors to shatter, and fires.

    Product
    Air Fryers and Air Fryer Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24158·2024-03-14

    Honeywell System Sensor L-Series Fire Alarm Sounders and Strobes Recall

    Honeywell is recalling about 29,000 System Sensor L-Series low frequency fire alarm sounders and strobes because they can malfunction and fail to alert people to a fire. No injuries have been reported, but two units showed low or no sound output during installation.

    Product
    System Sensor L-series low frequency Sounders and Strobes for residential apartments and commercial buildings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1023-2024·2024-03-13

    Frothy Monkey Spinach and Feta Croissants Recalled for Metal Fragments

    Bakery by Frothy Monkey is recalling Spinach & Feta Croissants sold in Tennessee and Alabama due to potential metal fragments. Consumers should not eat these croissants and should return them to the store.

    Product
    Frothy Monkey - Spinach & Feta Croissant - packaged and sold individually
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1247-2024·2024-03-13

    Aesculap Hasson Trocar Recall Due to Potentially Compromised Sterile Packaging

    Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.

    Product
    DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2024·2024-03-13

    Medical Device Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2024·2024-03-13

    Knee Implant Tibial Inserts Recalled for Sterile Packaging Breach

    Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2024·2024-03-13

    Medical device software defect may cause incorrect laboratory test results

    A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2024·2024-03-13

    TFNA Femoral Nail surgical implant recalled for sterility failure

    Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.

    Product
    TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2024·2024-03-13

    Howmedica X3 Triathlon CS Insert Recalled for Packaging Defects

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.

    Product
    X3 TRIATHLON CS INSERT NO 7 9 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2024·2024-03-13

    X3 Triathlon Orthopedic Insert Recalled Due to Potential Packaging Breaches

    Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.

    Product
    X3 TRIATHLON CS INSERT NO 6 10 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2024·2024-03-13

    Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2024·2024-03-13

    Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging

    FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.

    Product
    Synapse PACS - Version 7.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2024·2024-03-13

    Aesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk

    Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units distributed in the US and Canada.

    Product
    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1033-2024·2024-03-13

    Dried Tangerine Plum Recalled Due to Undeclared Sulfites

    Rong Shing Trading NY Inc is recalling 4.7oz bottles of Dried Tangerine Plum due to undeclared sulfites. Products distributed in Florida and New York with best-before date 05/31/2023 may be affected.

    Product
    Dried Tangerine Plum; packaged in 4.7oz (135g) clear plastic bottle; UPC 6928580580214
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1251-2024·2024-03-13

    Invacare Homecare and G-Series Bed Components Recalled for Weld Defects

    Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.

    Product
    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2024·2024-03-13

    FDA Recalls Tibial Inserts Due to Potential Sterile Packaging Breach

    Howmedica Osteonics is recalling tibial inserts due to potential breaches in sterile packaging. The breach could allow device contamination and increase post-operative infection risk.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2024·2024-03-13

    Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use

    Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide