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.

11351–11375 of 53044

  • HighCPSC·24703·2023-10-12

    Crystal Clear Sodium Hydroxide 2-lb Bags Lack Child-Resistant Packaging

    Family Health Products is recalling Crystal Clear Sodium Hydroxide sold on Amazon because the packaging is not child-resistant as required by law. The product poses a risk of chemical burns and eye irritation if accessed by children.

    Product
    Crystal Clear Sodium Hydroxide, 2 lb. bags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24008·2023-10-12

    Gevi Countertop Nugget Ice Makers Recalled Due to Laceration Hazard

    Gevi countertop nugget ice makers with model number GIMN-1102 and a date code before June 1, 2022, are being recalled because metal auger blades can break and create sharp metal pieces in the ice basket, posing a laceration risk. No injuries have been reported.

    Product
    Gevi Household Countertop Nugget Ice Makers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V682000·2023-10-12

    2023 Cadillac Lyriq Pedestrian Warning Sounds May Not Activate

    General Motors is recalling certain 2023 Cadillac Lyriq vehicles due to a software defect in the body control module. The pedestrian warning sounds may fail to activate, creating a crash risk.

    Product
    CADILLAC — CADILLAC LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24702·2023-10-12

    YourHealthToolkit Children's Weighted Blankets Recalled for Asphyxiation Hazard

    YourHealthToolkit is recalling about 280 children's 5-pound weighted blankets sold on Amazon.com from January through March 2020. A young child can become entrapped inside the blanket by unzipping it, posing a risk of death by asphyxiation.

    Product
    YourHealthToolkit 5-pound children's weighted blankets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V680000·2023-10-12

    2023 Toyota 4Runner Load Capacity Label Correction Recall

    Southeast Toyota Distributors is recalling certain 2023 Toyota 4Runner vehicles due to an incorrect load carrying capacity modification label. The error could result in vehicle overloading and increased crash risk.

    Product
    TOYOTA — TOYOTA 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24006·2023-10-12

    The FORT Children's Play Tents Recalled for Choking and Laceration Hazards

    About 13,250 FORT children's play tents are being recalled because magnets used to connect pieces can come loose, posing choking and laceration risks to young children. The manufacturer is no longer in business and offers no remedy.

    Product
    The FORT Children's Play Tents
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V681000·2023-10-12

    GMC Acadia and Cadillac Windshield Detachment Risk Recall

    General Motors is recalling 2023 GMC Acadia vehicles and certain 2024 Cadillac models due to windshields that may not be properly bonded to the vehicle body. A detached windshield during a crash could increase the risk of injury.

    Product
    GMC — GMC, CADILLAC ACADIA, XT6, XT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2024·2023-10-11

    Cardiac Guide Catheters Recalled for Incorrect Tip Curve Shape

    Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.

    Product
    Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0007-2024·2023-10-11

    Phenylephrine Injectable Syringes Recalled for Sterility Assurance

    Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2024·2023-10-11

    Mass Spectrometer Recalled for Risk of Flame and Electrode Ejection

    AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.

    Product
    Citrine Triple Quad Mass Spectrometer, Part Number 5063684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0004-2024·2023-10-11

    Injectable Lidocaine Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.

    Product
    lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0018-2024·2023-10-11

    Midazolam Injectable Solution Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.

    Product
    midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2024·2023-10-11

    Fentanyl Injectable Solution Recalled Over Sterility Concerns

    Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2023·2023-10-11

    IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety

    Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.

    Product
    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2024·2023-10-11

    Guider Softip XF Guide Catheter Recalled for Incorrect Tip Curve Shape

    Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from labeled specifications, affecting 1,086 units in Indiana.

    Product
    Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0072-2024·2023-10-11

    Medical Device Recall: LFS Flat Screen Support Arm Bracket Failure

    The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.

    Product
    LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0010-2024·2023-10-11

    FDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.

    Product
    Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide