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.

13176–13200 of 53086

  • HighNHTSA·23V369000·2023-05-25

    Jaguar I-PACE Battery Overheat May Increase Fire Risk

    Jaguar is recalling certain 2019-2024 I-PACE vehicles because the high-voltage battery may overheat, increasing the risk of fire. Owners should park and charge vehicles outside until repairs are complete.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V368000·2023-05-25

    Fontaine Recalls 2023-2024 Container Trailers Due to Missing Reflectors

    Fontaine Trailer Company is recalling 2023-2024 40-foot container trailers because they may be missing rear reflex reflectors, which reduces visibility and increases crash risk.

    Product
    FONTAINE — FONTAINE CONTAINER TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V371000·2023-05-25

    IC Bus school buses recalled for ABS warning light failure

    IC Bus school buses (2021–2024) are being recalled because the anti-lock brake system warning light fails to illuminate during malfunctions, preventing drivers from being alerted and increasing crash risk.

    Product
    IC BUS — IC BUS CESB, RESB, EVSB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V367000·2023-05-25

    2023 Cadillac Lyriq Battery Connection Defect May Cause Loss of Drive Power

    General Motors is recalling certain 2023 Cadillac Lyriq and 2022 GMC Hummer EV vehicles. Connections in the high-voltage battery pack may be out of position or incorrectly welded, potentially causing loss of drive power and increasing crash risk.

    Product
    CADILLAC — CADILLAC, GMC LYRIQ, HUMMER EV PICKUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23210·2023-05-25

    Janod Sweet Cocoon Activity Tables Recalled for Choking Hazard

    Juratoys is recalling about 5,080 Janod Sweet Cocoon Activity Tables because a detachable silver metal bell poses a choking hazard to children 12 months and older. Consumers should stop using the tables and contact Juratoys for a free repair kit.

    Product
    Janod Sweet Cocoon Activity Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V374000·2023-05-25

    2023 Nissan Rogue rear seat belt fasteners may loosen in crashes

    Certain 2023 Nissan Rogue vehicles have rear seat belt anchor fasteners that may not have been properly tightened and could loosen over time, potentially failing to restrain occupants in a crash.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V370000·2023-05-25

    2022-2024 International Trucks: ABS Warning Light Fails to Illuminate

    Navistar is recalling certain 2021-2024 International trucks and buses whose anti-lock brake system warning light fails to illuminate when malfunctions occur. Drivers will not be alerted to brake system problems, increasing the risk of crashes.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS LONESTAR, RH, LT, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23761·2023-05-25

    Bunch Bikes Recalls The Preschool Electric Bicycles Due to Excess Lead Paint

    Bunch Bikes is recalling about 150 units of The Preschool Electric Bicycles sold online from April 2020 through December 2022 because the paint contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    The Preschool Electric Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0641-2023·2023-05-24

    Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns

    Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.

    Product
    VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1600-2023·2023-05-24

    Fisher Wallace Stimulator Models Recalled for Battery Overheat and Burn Risk

    Fisher Wallace Stimulator Models FW-100 and FW-200 are being recalled because incorrectly installed batteries may cause the device to overheat, potentially resulting in burns. The recall affects 43,489 devices distributed nationwide and globally.

    Product
    Fisher Wallace Stimulator Models FW-100 and FW-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0602-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Deficiency

    Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0614-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0632-2023·2023-05-24

    PHENYLephrine HCl Injection Recalled for Lack of Sterility Assurance

    Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.

    Product
    PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0576-2023·2023-05-24

    Lorazepam Injection Vials Recalled Due to Manufacturing Quality Control Failures

    RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection due to discontinuation of the manufacturer's quality control program. The product may not meet specified identity, strength, quality, and purity standards.

    Product
    LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0605-2023·2023-05-24

    Cefepime for Injection Vials Recalled Over Sterility Concerns

    Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2023·2023-05-24

    Surgical Optical Trocars Recalled Due to Sterility Assurance Failure

    Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.

    Product
    YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0622-2023·2023-05-24

    Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue

    Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2023·2023-05-24

    Ampicillin Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2023·2023-05-24

    Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance

    IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.

    Product
    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2023·2023-05-24

    Urine Microscopy Analyzer Software Display Defect May Prevent Contamination Detection

    Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.

    Product
    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0629-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0592-2023·2023-05-24

    Ampicillin-Sulbactam Injection Recalled Due to Sterility Concerns

    FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0633-2023·2023-05-24

    Succinylcholine Injection recalled for lack of sterility assurance

    Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.

    Product
    Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
    Category
    Drug
    Distribution
    1 state