The Recall Desk

Hazard

Infection Risk recalls

1,010 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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.

126–150 of 1010

  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    American Contract Systems Surgical Kits Recalled Due to Unconfirmed Sterilization

    American Contract Systems is recalling 588 surgical procedure kits distributed in Illinois and Louisiana due to inability to confirm proper sterilization of certain components. The kits may not meet sterilization assurance requirements.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Surgical procedure kits recalled due to sterilization assurance concerns

    American Contract Systems Inc is recalling hysterectomy procedure kits from IL and LA due to inability to confirm sterilization assurance requirements were met.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2469-2025·2025-09-03

    Obstetric procedure kits recalled due to unconfirmed sterilization assurance

    American Contract Systems is recalling 781 medical procedure kits because the manufacturer cannot confirm sterilization was properly completed. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2467-2025·2025-09-03

    Medical Procedure Kits Recalled Due to Unconfirmed Sterilization

    American Contract Systems is recalling 6,617 medical procedure kits because the company cannot confirm sterilization requirements were met. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2465-2025·2025-09-03

    American Contract Systems Medical Procedure Kits Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling 1,233 medical procedure kits distributed in Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0591-2025·2025-08-27

    Pfizer Recalls Sodium Bicarbonate Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 15,750 vials of Sodium Bicarbonate Injection (8.4%, 50mEq/50mL) distributed nationwide due to lack of assurance of sterility. Lot LH2671, expiring 11/30/2026, may not meet required sterility standards for injectable medications.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2025·2025-08-13

    Guedel Airway Recalled Due to Potential Small Burr Contamination

    Intersurgical Inc is recalling 2,800 Guedel airways (Model 1112080, Lot 32414447) due to potential small burrs that could detach and be inhaled, causing airway obstruction or tissue damage. No injuries have been reported.

    Product
    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush Prefilled Syringe with Faulty Disinfecting Cap Poses Infection Risk

    Defective SwabCaps on SwabFlush prefilled syringes may reduce disinfection of luer access valves, potentially causing patient infection. The recall affects 1,427,100 units distributed nationwide and internationally.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2025·2025-07-30

    Ellik Evacuator surgical device sterilization instructions differ between language versions

    Olympus is recalling Ellik Evacuator Model 191-NRS due to discrepancies between sterilization instructions in Japanese-language product inserts and the manufacturer's English Instructions For Use. Sterilization instruction discrepancies may affect proper device preparation before use.

    Product
    Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2153-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep recalled due to sterility breach risk

    Medline Convenience Kits containing BD ChloraPrep applicators are being recalled due to potential open seals that could breach sterility and increase infection risk. The recall affects 960 units distributed in California, Florida, Pennsylvania, and Texas.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2155-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep Recalled for Open Seal

    Medline Convenience Kits containing BD ChloraPrep applicators are recalled for potential open seals that breach sterility and may cause patient infection. The 15,700 affected units were distributed to California, Florida, Pennsylvania, and Texas.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2135-2025·2025-07-30

    HSG Procedure Trays With Incorrect Sterility Labeling on Iodine Pouches

    CooperSurgical HSG Procedure Trays contain non-sterile iodine pouches incorrectly labeled as sterile. The mislabeling affects 171 units distributed nationwide.

    Product
    HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline Convenience Kits Recalled for Potential Sterility Breach Risk

    Medline Convenience Kits containing BD ChloraPrep Clear applicators are recalled due to potential open seals on packaging that may compromise sterility and lead to infection risk during surgical procedures.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2145-2025·2025-07-30

    Ellik Evacuator Adapter sterilization instructions differ between Japanese and English

    Olympus recalls Ellik Evacuator Adapter 190-NRS due to discrepancies between Japanese and English sterilization instructions that could lead to improper device sterilization.

    Product
    Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2137-2025·2025-07-30

    Endosee System Convenience Kits recalled for non-sterile iodine pouches

    CooperSurgical is recalling 475 units of Endosee System Convenience Kits with IV Tube due to non-sterile iodine pouches labeled as sterile. The kits were distributed nationwide to healthcare facilities.

    Product
    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2025·2025-07-23

    SwabCap Disinfecting Cap Needlefree Connector Seal Defect Recall

    ICU Medical is recalling SwabCap Disinfecting Caps due to a manufacturing defect that may prevent proper disinfection of needlefree connectors. The incomplete seal may cause isopropyl alcohol to evaporate, reducing effectiveness.

    Product
    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2025·2025-07-16

    Boston Scientific VersaCross Guide Wire Sterile Barrier Defect

    Boston Scientific is recalling VersaCross Access Solution guide wires due to potential holes in the sterile barrier pouch that may compromise device sterility and could lead to systemic infection.

    Product
    VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    Cardiac device recall due to potential sterile barrier compromise

    Boston Scientific is recalling the VersaCross RF Wire cardiac device due to potential holes in the sterile barrier pouch. These defects could compromise device sterility and potentially lead to systemic infection or sepsis.

    Product
    VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0490-2025·2025-07-02

    Injectable Sodium Chloride Recalled Due to Sterility Assurance Defect

    Fresenius Medical Care is recalling 3,651,468 containers of 0.9% Sodium Chloride Injection nationwide due to sterility assurance defects. Healthcare facilities should immediately discontinue use of affected batches.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0477-2025·2025-07-02

    LX Bioboost Plus Pre-filled Syringes Recalled for Sterility Assurance Failure

    LX Bioboost Plus pre-filled syringes are being recalled because the manufacturer cannot assure the product meets sterility requirements. Consumers should stop using the product and consult their healthcare provider.

    Product
    LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inve
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0485-2025·2025-07-02

    Tirzepatide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling 216 syringes of Tirzepatide/Cyanocobalamin Injectable (lot C03065F) because the manufacturer cannot assure the products are sterile. Patients should contact their healthcare provider.

    Product
    Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0482-2025·2025-07-02

    Tirzepatide injection syringes recalled due to lack of sterility assurance

    Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL) in pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.

    Product
    Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0496-2025·2025-07-02

    Prescription Eye Drops Recalled for Sterility Assurance Issues

    Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate eye drops nationwide due to lack of sterility assurance. Patients should verify their batch number and contact their healthcare provider.

    Product
    BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2025·2025-06-18

    Tecfen Medical 2.4mm Slit Knife Sterility Assurance Recall

    Tecfen Medical is recalling 115 units of the 2.4mm Slit Knife, Angled (Model QKN2461), an ophthalmic surgical instrument, due to sterility assurance concerns.

    Product
    Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2025·2025-06-18

    Ophthalmic surgical knives recalled due to sterility assurance concerns

    Tecfen Medical is recalling 38 units of MVR Sideport Knives (Model QKN2312) due to sterility assurance concerns. The surgical instruments used in eye procedures may pose an infection risk if sterility cannot be assured.

    Product
    Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
    Category
    Medical Device
    Distribution
    Distributed nationwide