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.

626–650 of 3438

  • HighFDA (Drugs)·D-0691-2023·2023-05-31

    Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0420-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0677-2023·2023-05-31

    Microplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls Microplegia Solution (HIGH POTASSIUM) nationwide due to FDA inspection findings questioning sterility assurance. 79 bags affected.

    Product
    Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2023·2023-05-24

    Surgical Optical Trocars Recalled Due to Sterility Assurance Failure

    Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.

    Product
    YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1580-2023·2023-05-24

    Breathing circuit swivel elbow recalled for inadequate sterilization instructions

    Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.

    Product
    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0625-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2023·2023-05-24

    DuraLife Breathing Circuit Extension Tube Recall Due to Inadequate Sterilization Instructions

    Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0606-2023·2023-05-24

    Cefepime for Injection Recalled Due to Sterility Assurance Concerns

    The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0643-2023·2023-05-24

    VANComycin Injectable Recalled for Lack of Sterility Assurance

    Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.

    Product
    VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0600-2023·2023-05-24

    Ampicillin and Sulbactam for Injection recalled nationwide for sterility assurance deficiency

    Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0607-2023·2023-05-24

    Cefepime for Injection recalled nationwide for lack of sterility assurance

    Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0591-2023·2023-05-24

    Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns

    Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0636-2023·2023-05-24

    Vancomycin injection recalled for lack of sterility assurance

    Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

    Product
    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1602-2023·2023-05-24

    YelloPort Elite Optical Trocars Recalled for Sterility Assurance Failure

    YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.

    Product
    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1582-2023·2023-05-24

    FDA Recalls DuraLife Silicone Breathing Tube Extension Over Sterilization Guidance

    Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Over Sterility Assurance Failure

    The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2023·2023-05-24

    FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance

    Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.

    Product
    VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0631-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2023·2023-04-19

    Step Bladeless Trocars recalled for sterilization failure

    Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

    Product
    Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2023·2023-04-12

    Endoscopic vessel harvesting system recalled for sterilization defect

    900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.

    Product
    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2023·2023-04-12

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure

    Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.

    Product
    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2023·2023-03-22

    BD Insulin Syringes Recalled for Sterility Defect

    Becton Dickinson recalls 1.9 million BD Insulin Syringes due to a nonsterility defect that could expose patients to pathogenic microorganisms and local infection risk.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe 0.5mL Recalled for Nonsterility Risk

    Becton Dickinson is recalling approximately 1.1 million BD Ultra-Fine Insulin Syringes due to nonsterility concerns. The affected syringes may expose patients to pathogenic microorganisms and risk of local infection.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2023·2023-03-22

    BD Ultra-Fine II insulin syringes recalled for sterility defect

    Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.

    Product
    BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2023·2023-03-22

    BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk

    Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
    Category
    Medical Device
    Distribution
    Distributed nationwide