The Recall Desk

Hazard

Infection recalls

2,547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,547
Critical
31
Severe
1,678
Most recent
2026-09-09

Of the 2,547 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,678 (66%) 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 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.

2001–2025 of 2547

  • HighFDA (Devices)·Z-0310-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 76 Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0252-2015·2014-12-10

    Customed Wound Management Tray II Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0247-2015·2014-12-10

    Customed Wound Management Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0300-2015·2014-12-10

    Customed Dressing Change Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0408-2015·2014-12-10

    Customed Plastic Surgery Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0271-2015·2014-12-03

    Perry Drug Recalls Cyclosporine Eye Drops Due to Sterility Concerns

    Perry Drug Inc. is recalling Cyclosporine 0.045% eye drops due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0419-2015·2014-12-03

    Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise

    Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0251-2015·2014-11-26

    Abrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes

    Abrams Royal Pharmacy is recalling 50 syringes of a compounded lidocaine and bupivacaine mixture due to non-sterility. The products were distributed in Texas.

    Product
    Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1591-2014·2014-11-26

    Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    PATIENT TRACKER 9733534XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2015·2014-11-12

    Creative Compounds Recalls Ceftazidime Syringes Due to Sterility Concerns

    Oregon Compounding Centers is recalling Ceftazidime syringes because quality control issues observed during an FDA inspection may compromise sterility assurance.

    Product
    CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0182-2015·2014-11-12

    FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.

    Product
    CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0225-2015·2014-11-12

    Tobramycin Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Tobramycin solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0208-2015·2014-11-12

    FDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Omnipaque injectable vials due to quality control issues affecting sterility assurance.

    Product
    OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0175-2015·2014-11-12

    Recall of Injectable Ascorbic Acid Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Ascorbic Acid (Vitamin B) due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0223-2015·2014-11-12

    FDA Recalls Compounded Testosterone Cypionate Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance.

    Product
    TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0137-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyclosporine/corn oil, due to quality control observations that risk sterility assurance.

    Product
    Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Hyaluronidase base vehicle, due to quality control issues affecting sterility assurance.

    Product
    Hyaluronidase base vehicle (PF) solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Morphine Sulfate Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate injectables due to quality control observations that present a risk to sterility assurance.

    Product
    Morphine sulfate (PF) 20 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix 8.3 low dose, due to quality control issues affecting sterility assurance.

    Product
    Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0131-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone injection solutions, due to quality control issues affecting sterility assurance.

    Product
    Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling sodium tetradecyl sulfate 1% injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0065-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including calcium chloride, due to quality control observations that risk sterility assurance.

    Product
    Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2014·2014-09-10

    Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits

    Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.

    Product
    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Su
    Category
    Drug
    Distribution
    2 states