The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 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 993 (29%) are Severe.

Which agencies issued them

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.

1376–1400 of 3438

  • HighFDA (Devices)·Z-0220-2020·2019-11-06

    LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure

    LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.

    Product
    SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 1,759 cases of sterile Co-Flex LF2 wound dressings because of incomplete packaging seals, which may compromise sterility.

    Product
    Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues

    Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

    Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2020·2019-10-23

    Xodus Medical Recalls Cautery Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2020·2019-10-23

    Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC Bundle VanTex kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2020·2019-10-16

    Centurion CVC Insertion Bundle Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling CVC Insertion Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2020·2019-10-16

    Centurion CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.

    Product
    CVC BUNDLE, 20CM, 3L, PI ECVC5120A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2020·2019-10-16

    Centurion Medical CVC Safety Bundle Recalled for Connector Fluid Leakage

    Centurion Medical Products is recalling CVC Triple Lumen Safety Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2020·2019-10-16

    Centurion Medical Central Line Bundle Recalled for Fluid Droplet Risk

    Centurion Medical is recalling central line bundles containing a BD MaxZeroNeedleess Connector due to the potential for fluid droplets to separate from the sealed surface after disconnection.

    Product
    CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2020·2019-10-16

    Centurion Medical Recalls Sorbaview IV Kits Due to Fluid Droplet Risk

    Centurion Medical Products Corporation is recalling Sorbaview IV kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    IV KIT - SORBAVIEW IVS3475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC BUNDLE, 20CM, 4L, PI ECVC5095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE WITHOUT CATH CVI4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2020·2019-10-09

    KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.

    Product
    Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0045-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Carnitine vials because the company cannot ensure the product is sterile. The recall covers 6,447 vials distributed nationwide.

    Product
    L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.

    Product
    L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.

    Product
    Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0097-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1850-2019·2019-09-18

    FDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns

    AmEx Pharmacy is recalling Bevacizumab intravitreal injections because the product lacks assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.

    Product
    Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1852-2019·2019-09-18

    Pfizer Recalls Bacteriostatic Water Vials Due to Sterility Concerns

    Pfizer is recalling 185,700 vials of Bacteriostatic Water for Injection due to a lack of assurance of sterility. The product was distributed nationwide in the US and Puerto Rico.

    Product
    BACTERIOSTATIC WATER — BACTERIOSTATIC WATER (BACTERIOSTATIC WATER)
    Category
    Drug
    Distribution
    Distributed nationwide