The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all infection risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1926–1950 of 3429

  • SevereFDA (Drugs)·D-0721-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.

    Product
    HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0756-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.

    Product
    PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0732-2017·2017-05-24

    Key Pharmacy Recalls PGE1 Injection Due to Sterility Assurance Concerns

    Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, 40mcg/mL, due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2017·2017-05-24

    Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.

    Product
    MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0735-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.

    Product
    TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2017·2017-05-24

    Key Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Chloride Inhalation Solution because the firm cannot assure the sterility of the product.

    Product
    SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0766-2017·2017-05-24

    Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.

    Product
    GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0738-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Drug Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2017·2017-05-24

    Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.

    Product
    PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0772-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot ensure the products are sterile.

    Product
    PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1906-2017·2017-05-10

    Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads

    Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches

    Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2017·2017-05-03

    Isomeric Pharmacy Recalls Phenylephrine and Tropicamide Ophthalmic Drops

    Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5% and Tropicamide 1% ophthalmic drops due to a lack of assurance of sterility.

    Product
    Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Acetonide Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0682-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0684-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

    Product
    Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2017·2017-04-19

    Windstone Medical Recalls Ortho Basic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2017·2017-04-19

    Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2017·2017-04-19

    Windstone Medical Recalls Cataract Packs Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 7,508 cataract packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2017·2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

    ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2017·2017-04-19

    Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2017·2017-04-19

    Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide