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.

9126–9150 of 53036

  • HighFDA (Food)·F-1177-2024·2024-05-01

    Amy's Kitchen Enchilada Verde Whole Meal Recalled for Listeria Contamination

    Amy's Kitchen Enchilada Verde frozen meals are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed to 21 U.S. states.

    Product
    Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1608-2024·2024-05-01

    NexGen CR-Flex Femoral Components Recalled for Bonding Defect

    Zimmer is recalling 5,546 units of NexGen CR-Flex Femoral Components due to a manufacturing defect where the fiber metal pad fails to bond properly to the substrate. Patients with these implants should contact their healthcare provider.

    Product
    NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2024·2024-05-01

    Palindrome Precision H Chronic Catheter Kit may lack labeled heparin coating

    Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.

    Product
    Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2024·2024-05-01

    Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery

    SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.

    Product
    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1688-2024·2024-05-01

    PIEZON Bottle May Disassemble Under Pressure During Dental Use

    FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.

    Product
    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0472-2024·2024-05-01

    Prescription Drug Recall: Diltiazem Extended-Release Capsules Fail Dissolution Test

    Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2024·2024-05-01

    Cleaner Bottles May Disassemble Under Pressure During Treatment

    EMS CLEANER BOTTLES (Model EG-1000) for dental prophylaxis systems may disassemble under pressure during treatment or storage. FDA Class II recall; no injuries reported.

    Product
    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2024·2024-05-01

    Philips Patient Information Center iX UPS devices recalled for potential power failure

    Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.

    Product
    Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2024·2024-05-01

    Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage

    Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.

    Product
    Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2024·2024-05-01

    Hip implant recalled for acetabular shell deburring defect

    Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.

    Product
    TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2024·2024-05-01

    Dialysis Catheters Recalled Due to Missing Heparin Coating

    Certain Palindrome Precision HSI dialysis catheters do not have the heparin coating indicated on the label, which could reduce their protective benefits during dialysis procedures.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2024·2024-05-01

    Hip Implant Acetabular Shell Recalled for Manufacturing Defect

    Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2024·2024-05-01

    TRIDENTII HEMI hip prosthesis recalled for manufacturing defect

    Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER52E hip prostheses due to excessive deburring on the acetabular shell. The defect may increase risk of hip dislocation in high-risk patients.

    Product
    TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2024·2024-05-01

    Hip replacement acetabular shell recalled for excessive deburring

    Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.

    Product
    TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2024·2024-05-01

    TRIDENTII HEMI hip implant recalled for acetabular shell manufacturing defect

    Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER48D hip implant because the acetabular shell may have excessive deburring, resulting in a smooth surface on the shell edge.

    Product
    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2024·2024-05-01

    Lead Wire Replacement Parts Recalled for Sheath Damage and Treatment Signal Loss

    EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.

    Product
    48" Lead Wires, Replacement Part Number: 1067724-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2024·2024-05-01

    Hip replacement acetabular shell recalled for excessive deburring

    Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2024·2024-05-01

    Hip implant acetabular shell manufacturing defect recall affects patients

    Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER44B hip implants due to excessive deburring on the acetabular shell edge. The recalled lot was distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V299000·2024-04-29

    Highland Ridge RV Recalls Trailers Due to Overheating Circuit Board Fire Risk

    Highland Ridge RV is recalling 681 model year 2022-2023 trailers because an LED backlight circuit board may overheat, increasing the risk of a fire.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT, HIGHLAND RIDGE FW OPEN RANGE, SILVERSTAR, MESA RIDGE XLT, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V301000·2024-04-29

    Motorhome cooktop control boards can overheat and cause fire

    Newmar is recalling certain 2022 Bay Star motorhomes because the LED backlight circuit board in the cooktop range may fail and overheat.

    Product
    NEWMAR — NEWMAR BAY STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V303000·2024-04-29

    Alliance RV Recalls 2024 Avenue Travel Trailers Due to Wiring Defect

    Alliance RV is recalling 2024 Avenue travel trailers because an improperly wired inverter circuit could cause a breaker to overheat and increase fire risk.

    Product
    ALLIANCE RV — ALLIANCE RV AVENUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V300000·2024-04-29

    Starcraft Recalls 2023 GSL Fifth Wheel Trailers Due to Fire Risk

    Starcraft RV is recalling 2023 GSL fifth wheel trailers because the cooktop LED backlight circuit board may overheat, increasing the risk of a fire.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW STARCRAFT GSL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V305000·2024-04-29

    Reading Truck Equipment Recalls RM-78 Cranes Due to Taillight Height

    Reading Truck Body LLC is recalling 2022-2024 RM-78 crane bodies because taillights may be mounted too high, reducing visibility and increasing crash risk.

    Product
    READING TRUCK EQUIPMENT — READING TRUCK EQUIPMENT RM-78 CRANE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V295000·2024-04-26

    Winnebago motorhome cooktop circuit boards may fail and overheat

    Winnebago Industries is recalling certain 2021-2025 motorhomes because the LED backlight circuit board in the cooktop range may fail and overheat. 1,166 units affected.

    Product
    WINNEBAGO — WINNEBAGO VITA, CAMBRIA, PORTO, FORZA
    Category
    Vehicle
    Distribution
    Distributed nationwide