The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

976–1000 of 29080

  • SevereFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled Over Sterility Concerns

    Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0530-2026·2026-03-04

    Frozen fish balls 200g recalled as Class I for undeclared allergens

    Min Jiang Food Store, trading as Koi Koi Trading, is recalling frozen Fish Ball in 200 g packs because of undeclared wheat and sesame. The FDA has classified this recall as Class I.

    Product
    Fish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1467-2026·2026-03-04

    Medline Dialysis Kits Recalled Over Tego Connector Seal Defects

    Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.

    Product
    Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2026·2026-03-04

    Reverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling

    Encore Medical, LP is recalling 20 Reverse Shoulder Prosthesis implants due to incorrect labeling. The recall affects nationwide distribution across multiple US states.

    Product
    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2026·2026-03-04

    Olympus Inner Sheath 21 Fr. Model A2660T Medical Device Recall

    Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.

    Product
    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1429-2026·2026-03-04

    Hitachi Proton Beam Therapy System Recall Over Positioning Software Issue

    Hitachi is recalling one Proton Beam Therapy System due to a software anomaly in the patient positioning system that may cause positional discrepancy during treatment.

    Product
    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1474-2026·2026-03-04

    Remel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery

    Remel, Inc is recalling 97 units of Campy CVA Medium 100/PK, lot R01272, due to customer complaints reporting low to no recovery of Campylobacter Jejuni ATCC 33291. The product was distributed nationwide in AZ, CO, IL, NJ, OH, TN, and WA.

    Product
    Campy CVA Medium 100/PK, R01272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·005-2026-EXP·2026-03-03

    Ajinomoto Recalls Chicken and Pork Fried Rice Due to Glass Contamination

    Ajinomoto Foods North America is expanding a recall for frozen fried rice, ramen, and shu mai products due to possible glass contamination. No injuries have been reported.

    Product
    Ajinomoto Foods North America — Ajinomoto Foods North America, Inc. Expands Recall for Chicken and Pork Fried Rice, Ramen, and Shu Mai Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·26286·2026-02-26

    Tubby Tots Fizzy Flask Bath Magic Bath Foam Sets Recalled for Impact Hazard

    Surreal Brands is recalling Tubby Tots Fizzy Flask Bath Magic bath foam sets because moisture can build up pressure in the container, causing pieces to eject forcefully.

    Product
    Tubby Tots Fizzy Flask Bath Magic bath foam set
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V113000·2026-02-26

    GM Recalls 2012-2013 Buick Regal for Rear Suspension Defect

    General Motors is recalling 2012-2013 Buick Regal vehicles in 23 states due to improper corrosion protection on rear suspension toe links, which may fracture and cause loss of control.

    Product
    BUICK — BUICK REGAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V111000·2026-02-26

    IC Bus school bus brake lines may be damaged and leak

    International is recalling certain 2023-2027 IC Bus CESB school buses because the brake lines may have been installed with incorrect hardware, which can damage the lines and cause a leak.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26285·2026-02-26

    Somgem and Yomin Lighters Recalled Due to Fire and Burn Hazards

    Somgem and Yomin brand lighters are being recalled because they lack required child-resistant mechanisms, posing a risk of serious injury or death from fire and burns.

    Product
    Somgem Lightweight Tiny Pinky Pig and Yomin Toilet Lighters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26283·2026-02-26

    Dupray Neat Steam Cleaners Recalled Due to Risk of Burn and Serious Injury

    Dupray USA is recalling Dupray Neat Steam Cleaners because the boiler can rupture, posing a risk of burns or serious injury. Consumers should stop using the device immediately and contact the manufacturer for a free replacement safety cap.

    Product
    Dupray Neat Steam Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0516-2026·2026-02-25

    Frozen Cooked Shrimp Recalled Over Cesium-137 Contamination Risk

    H & N Group Inc. is recalling frozen cooked medium shrimp due to potential contamination with Cesium-137 from manufacturing under insanitary conditions. The product was distributed to approximately 30 retail locations in the greater Houston and Gulf Coast areas.

    Product
    Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1385-2026·2026-02-25

    Medline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns

    Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1387-2026·2026-02-25

    Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues

    Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0511-2026·2026-02-25

    IKM Aluminum Saucepan Recalled Over Lead Contamination Risk

    Lotus Mom Corporation is recalling 56 units of the IKM Aluminum Saucepan 9" with Wooden Handle due to potential leachable lead contamination. The product was distributed in California and Colorado.

    Product
    IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MART
    Category
    Consumer Product
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Over Adverse Events

    Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1397-2026·2026-02-25

    Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration

    Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2026·2026-02-25

    Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration

    Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1365-2026·2026-02-25

    Integra CVS Wound Dressing Recall Over Sterile Barrier Breach Risk

    Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.

    Product
    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide