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.

2076–2100 of 2547

  • SevereFDA (Drugs)·D-1215-2014·2014-04-16

    Zions RX Formulations Recalls Potassium Phosphates Vials Due to Sterility Concerns

    Zions RX Formulations is recalling 95 vials of Potassium Phosphates due to a lack of assurance of sterility caused by poor aseptic practices.

    Product
    Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1218-2014·2014-04-16

    Zions RX Formulations Recalls Bupivacaine Due to Sterility Concerns

    Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.

    Product
    Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1217-2014·2014-04-16

    Zions RX Formulations Recalls Sodium Bicarbonate Injectable Units

    Zions RX Formulations is recalling 610 units of Sodium Bicarbonate 8.4% injectable products due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1424-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1417-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1425-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1418-2014·2014-04-16

    Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise

    Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.

    Product
    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1422-2014·2014-04-16

    Aspen Surgical Recalls Sterile Bulb Evacuator Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially increasing infection risk.

    Product
    Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1428-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1426-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.

    Product
    19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1431-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1320-2014·2014-04-09

    Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits

    Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.

    Product
    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2014·2014-03-19

    Boston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns

    Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.

    Product
    Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1102-2014·2014-03-12

    Bleomycin Sulfate Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml due to quality control issues affecting sterility assurance.

    Product
    Bleomycin Sulfate 1unit/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1069-2014·2014-03-05

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.

    Product
    VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2014·2014-02-19

    Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing

    Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.

    Product
    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-1066-2014·2014-02-12

    Apothecure Recalls Sterile Compounded Products Due to Sterility Assurance Concerns

    Apothecure, Inc. is recalling all lots of sterile compounded products within expiry due to lack of sterility assurance identified during an FDA inspection.

    Product
    The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1052-2014·2014-02-05

    NuVision Pharmacy Recalls Sermorelin/GHRP-6 Vials Due to Sterility Concerns

    NuVision Pharmacy is recalling 122 vials of Sermorelin/GHRP-6 due to lack of sterility assurance identified during an FDA inspection.

    Product
    Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-443-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.

    Product
    QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, pr
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-436-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Injectable Drug Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-428-2014·2014-01-22

    Lidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-439-2014·2014-01-22

    Phenylephrine/Tropicamide Ophthalmic Solution Recalled for Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.

    Product
    Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state