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.

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.

251–275 of 3438

  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    VersaCross RF wire lots may have a punctured sterile barrier pouch

    The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.

    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 (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation vitrectomy packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2025·2025-07-16

    Torflex transseptal guiding sheath kits may have a punctured sterile pouch

    Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2025·2025-07-02

    Methylcobalamin Injectable Pre-filled Syringe Recalled for Sterility Concerns

    Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1961-2025·2025-07-02

    MicroMyst Applicator recalled due to lack of sterility assurance

    Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.

    Product
    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2025·2025-07-02

    NAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.

    Product
    Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0484-2025·2025-07-02

    Tirzepatide Injections recalled due to lack of sterility assurance

    Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0487-2025·2025-07-02

    NAD+ Injectable Solution Recalled Due to Lack of Sterility Assurance

    Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.

    Product
    Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2025·2025-07-02

    Semaglutide 2.5 mg/mL pre-filled syringe recall for sterility assurance

    Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.

    Product
    Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2025·2025-06-18

    Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall

    Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.

    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
  • SevereFDA (Devices)·Z-1963-2025·2025-06-18

    Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling

    Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.

    Product
    Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to…
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1952-2025·2025-06-18

    Tecfen Medical 2.8mm Slit Knife Angled Sterility Assurance Recall

    Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2025·2025-06-18

    Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall

    Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.

    Product
    Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2025·2025-06-18

    Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall

    Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2025·2025-06-18

    Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall

    Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.

    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2025·2025-06-18

    Tecfen Medical 15 degree Stab Knife sterility assurance recall

    Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2025·2025-06-11

    Palindrome Precision Chronic Hemodialysis Catheter Sport Pack Recalled

    Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. Affected units were distributed worldwide including the US, Canada, and Mexico.

    Product
    Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2025·2025-06-11

    MAHURKAR Chronic Hemodialysis Catheter recalled for sterile barrier defect

    Mozarc Medical is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack units due to a potential breach in sterile barrier packaging that could compromise the product's sterility.

    Product
    MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2025·2025-06-11

    Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack recalled

    Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.

    Product
    Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Triple Lumen Recall

    Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter recalled for sterility defect

    Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall

    Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

    Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2025·2025-05-14

    GALT Centeze Catheter recalled due to potential sterile packaging seal failure

    Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.

    Product
    GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
    Category
    Medical Device
    Distribution
    Distributed nationwide