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.

2626–2650 of 3429

  • SevereFDA (Drugs)·D-0009-2016·2015-10-21

    Apotex Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because preservative testing failed, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2016·2015-10-14

    FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0070-2016·2015-10-14

    FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0052-2016·2015-10-14

    Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a s
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0074-2016·2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0006-2016·2015-10-14

    Sermorelin Injection Recalled Due to Sterility Assurance Concerns

    DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder because an FDA inspection found it was not compounded in an appropriate area, potentially compromising sterility.

    Product
    Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0068-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.

    Product
    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0078-2016·2015-10-14

    FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proce
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0075-2016·2015-10-14

    FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a s
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0033-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgic
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0059-2016·2015-10-14

    FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0081-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 54 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surg
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0088-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits

    Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because the equipment glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0093-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Vascular Surgical Kits

    Resource Optimization & Innovation LLC is recalling 500 sterile vascular surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0050-2016·2015-10-14

    Resource Optimization & Innovation Recalls 516 Sterile Lap Chole Surgical Kits

    Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgica
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0086-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 388 sterile C Section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a sur
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0046-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 144 sterile C-section surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical p
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0084-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits

    Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical p
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0080-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 1,233 sterile surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0039-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Laparoscopy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 400 sterile laparoscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0058-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 125 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0028-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 26 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0029-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk

    Resource Optimization & Innovation LLC is recalling 7,904 sterile surgical kits because the equipment glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proc
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0041-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk

    Resource Optimization & Innovation LLC is recalling 1,220 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proc
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0102-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Titanium Rib Surgical Kits

    Resource Optimization & Innovation LLC is recalling 62 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
    Category
    Medical Device
    Distribution
    3 states