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.

8701–8725 of 29123

  • SevereFDA (Drugs)·D-0227-2021·2021-01-20

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0734-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

    Boston Scientific is recalling 207 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0838-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0813-2021·2021-01-20

    Fresenius Recalls NaturaLyte Liquid Acid Concentrate Bottles

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0735-2021·2021-01-20

    Recall of Lotus Edge Valve System Transcatheter Aortic Valve Prosthesis Due to Deployment Locking Failure

    Boston Scientific recalls 278 Lotus Edge Valve Systems due to a failure in visual inspection that prevents proper valve locking during deployment, potentially preventing delivery system release.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0828-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recall Due to Low Sodium Levels

    Fresenius Medical Care is recalling 198 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0736-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk

    Boston Scientific is recalling 386 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0728-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

    Boston Scientific is recalling 219 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0852-2021·2021-01-20

    Philips Emission Computed Tomography System Software Defect Recall

    Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.

    Product
    Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0816-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2021·2021-01-20

    Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect

    Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.

    Product
    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2021·2021-01-20

    Paroex Oral Rinse Recalled for Potential Bacterial Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.

    Product
    Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling 176 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0203-2021·2021-01-20

    B&G Foods Recalls Garlic Powder With Undeclared Soy Allergen

    B&G Foods is recalling Food Club Garlic Powder because it contains bacon-flavored bits with undeclared soy, a major allergen.

    Product
    Food Club Garlic Powder, 5.37 ounce bottles, 12 bottles per case. " Best 324A0 C By NOV 19 22 / Best 325A0 By NOV 20 22
    Category
    Food
    Distribution
    4 states
  • SevereCPSC·21070·2021-01-19

    Rapala Recalls Rechargeable Fillet Knives Due to Fire Hazard

    Rapala USA is recalling about 128,000 rechargeable fillet knives because the batteries can overheat and catch fire if non-Rapala chargers are used.

    Product
    Rapala® Rechargeable Fillet Knives (Item No. RRFN)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2021·2021-01-15

    Nestlé Prepared Foods recalls pepperoni hot pockets due to possible foreign matter contamination

    The USDA Food Safety and Inspection Service is recalling approximately 762,615 pounds of not-ready-to-eat pepperoni hot pockets because they may contain glass and hard plastic fragments. One consumer reported a minor oral injury, but no additional illness cases were reported.

    Product
    Nestlé Prepared Foods Recalls Not-Ready-to-Eat Pepperoni Hot Pockets Product Due to Possible Foreign Matter Contamination
    Category
    Food
    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-0176-2021·2021-01-13

    Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures

    Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.

    Product
    ZERBAXA — ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
    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 (Drugs)·D-0190-2021·2021-01-13

    SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2021·2021-01-13

    SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide