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.

8726–8750 of 29123

  • SevereFDA (Drugs)·D-0208-2021·2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,239 syringes of Succinylcholine Chloride 200 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0189-2021·2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0773-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 13 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0776-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 8 units of the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0187-2021·2021-01-13

    SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.

    Product
    Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0210-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0785-2021·2021-01-13

    Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

    Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0194-2021·2021-01-13

    SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0196-2021·2021-01-13

    Bonduelle Mixed Veg Recall Issued Due to Metal Fragment Risk

    Bonduelle Canada Inc. is recalling GE Mixed Veg products because they may contain metal fragments. Consumers should stop using the product.

    Product
    GE Mixed Veg (4) 12/32oz/GE Mixed Veg (4) 12/32oz - packed in corrugated cases of 12 individual printed poly bags
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0800-2021·2021-01-13

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.

    Product
    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V007000·2021-01-13

    Freightliner Cascadia Trucks Recalled for Steer Tire Tread Separation and Blow-Out Risk

    Daimler Trucks North America is recalling 2020-2022 Freightliner Cascadia sleeper trucks with certain Bridgestone steer tires. The tires may experience tread separation or blow-outs, risking loss of vehicle control and crashes.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0194-2021·2021-01-13

    Bonduelle Frozen Carrot Cubes Recalled for Metal Fragments

    Bonduelle Canada Inc. is recalling specific lots of frozen carrot cubes and diced carrots due to the potential presence of metal fragments.

    Product
    HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos 3/8" 1/25LB - bag in box product in corrugated case; Classic Carot Cubes 12/2LB/Classic DCD Carrots 12/2LB - corrugated cases of 12 individual
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0216-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0775-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery Systems Due to Fitting Detachment Risk

    Boston Scientific is recalling 38 units of AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0202-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0200-2021·2021-01-13

    American Blue Ribbon Recalls French Silk Pies Due to Undeclared Pecans

    American Blue Ribbon Holdings LLC is recalling 9-inch French Silk Base pies because they contain undeclared pecans, a major food allergen.

    Product
    9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0778-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Detachment Risk

    Boston Scientific is recalling 78 units of Hot AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0195-2021·2021-01-13

    Bonduelle Carrot and Peas Recalled for Potential Metal Fragments

    Bonduelle Canada Inc. is recalling 4,296 cases of HRV Carrot & Peas due to potential metal fragments. The product was distributed to nine states.

    Product
    HRV Carot.&Pois 1/20LB/HRV Carrot & Peas 1/20LB - bag in box product in corrugated case
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0199-2021·2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Lidocaine HCl 1% syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
    Category
    Drug
    Distribution
    Distributed nationwide