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.

751–775 of 3429

  • HighFDA (Drugs)·D-1534-2022·2022-09-21

    FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure

    Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.

    Product
    QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2022·2022-09-21

    Roadrunner UniGlide wire guide recalled for potential sterility compromise

    Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2022·2022-09-14

    Cysto Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.

    Product
    Various Cysto Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1699-2022·2022-09-14

    Surgical instrument convenience packs recalled for inadequate sterilization validation

    American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1701-2022·2022-09-14

    Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

    American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

    Product
    Various ob/gyn packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1697-2022·2022-09-14

    Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation

    American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.

    Product
    Breast Abdominoplasty Pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1689-2022·2022-09-14

    Angiography Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.

    Product
    Various Angiography packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1690-2022·2022-09-14

    Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various Angiography/Cath Lab packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1692-2022·2022-09-14

    PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles

    American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various PICC Line, Central Line Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1683-2022·2022-09-14

    Medline Chest Tube Kit Recalled for Non-Sterile Tape Component

    Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.

    Product
    Medline CHEST TUBE REORDER NO: DYNJ36762A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2022·2022-09-14

    CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging

    Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.

    Product
    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2022·2022-08-24

    Surgical forceps recalled due to compromised sterile barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1245-2022·2022-07-27

    Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1252-2022·2022-07-27

    Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Fentanyl Citrate Injection nationwide due to lack of assurance of sterility. Approximately 9,410 bags distributed to healthcare facilities are affected.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1251-2022·2022-07-27

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1248-2022·2022-07-27

    Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1195-2022·2022-07-20

    Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure

    Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1217-2022·2022-07-20

    Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.

    Product
    Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2022·2022-07-20

    Glutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues

    Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.

    Product
    Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1220-2022·2022-07-20

    Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.

    Product
    Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1197-2022·2022-07-20

    Biotin 5mg/mL injection recalled for lack of sterility assurance

    Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.

    Product
    Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide