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.

226–250 of 3429

  • HighFDA (Drugs)·D-0676-2025·2025-10-08

    Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns

    Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.

    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-0025-2026·2025-10-08

    Reprocessed 2.0mm laser atherectomy catheters recalled for sterile packaging breaches

    Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2026·2025-10-08

    Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2025·2025-09-10

    Sterile cover kits recalled because elastic bands may detach during surgery

    Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.

    Product
    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2025·2025-09-03

    Surgical kits recalled because Foley tray inserts carry incorrect product information

    Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.

    Product
    Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush prefilled syringes carry SwabCaps with a compromised seal

    SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline C-section prep kits contain ChloraPrep applicators with open seals

    Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2154-2025·2025-07-30

    Medline IV start lab draw kits contain ChloraPrep with open seals

    Medline IV START KIT LAB DRAW-SH convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 184 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2153-2025·2025-07-30

    Medline labor triage kits contain ChloraPrep applicators with open seals

    Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2105-2025·2025-07-16

    VersaCross transseptal sheath kits may have a punctured sterile barrier pouch

    VersaCross Transseptal 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
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    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 Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 atri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak surgical kits may have damaged lidding compromising sterility

    Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2025·2025-07-16

    VersaCross access kits may have a hole in the sterile pouch

    VersaCross Access Solution 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
    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-2109-2025·2025-07-16

    Alcon Constellation procedure packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined 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 Constellati
    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-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 (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-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-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