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.

2876–2900 of 3429

  • HighFDA (Devices)·Z-1803-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves

    Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves

    Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1121-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Glutathione Inhalation Solution Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.

    Product
    Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1125-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1127-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-1715-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1090-2015·2015-06-03

    Advanced Physician Solutions Recalls Cyanocobalamin Injectable Due to Sterility Concerns

    Advanced Physician Solutions is recalling 77 vials of Cyanocobalamin injectable nationwide due to a lack of assurance of sterility.

    Product
    CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1074-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Methylcobolamin Injections Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 56 vials of Methylcobolamin injections in New York due to a lack of assurance of sterility.

    Product
    Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1599-2015·2015-05-20

    FDA Recalls VenaSeal Vascular Closure Systems Due to Sterility Concerns

    The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.

    Product
    VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1567-2015·2015-05-13

    Stryker Recalls Wound Drains and Ambulating Bulb for Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain and ambulating bulb products due to a potential sterility breach in the packaging.

    Product
    1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain devices because of a potential sterility breach in the packaging.

    Product
    1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2015·2015-05-13

    Stryker Recalls Trocar Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.

    Product
    3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2015·2015-05-13

    Stryker Recalls Ambulating Bulbs Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.

    Product
    Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker Instruments is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1566-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.

    Product
    3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2015·2015-05-06

    CareFusion LightWand Stylet Recalled for Sterile Packaging Breach Risk

    Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.

    Product
    CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2015·2015-05-06

    Vital Signs LightWand Stylet Recalled for Sterile Packaging Breach

    Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.

    Product
    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2015·2015-04-15

    Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks

    Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.

    Product
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1396-2015·2015-04-15

    Bacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors

    Bacterin International is recalling 63 Instrument Kits for OsteoSponge SC grafts because the instructions for use contain incorrect sterilization parameters.

    Product
    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instrumen
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1351-2015·2015-04-08

    Medcomp Recalls Catheter Insertion Kits Due to Sterilization Defect

    Medcomp is recalling specific catheter insertion kits because one biological indicator failed during the sterilization process, potentially compromising sterility.

    Product
    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the device
    Category
    Medical Device
    Distribution
    0 states