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.

Which agencies issued them

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.

2676–2700 of 3429

HighFDA (Devices)·Z-0057-2016·2015-10-14
FDA Recalls 114 Sterile Head and Neck Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 114 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800549, Sterile, ET0638 - Head & Neck - 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-0045-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 222 sterile C Section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800514, Sterile, LD0592 - 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 surgic
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0077-2016·2015-10-14
FDA Recalls 100 Neurosurgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 100 sterile neurosurgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing 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 procedure
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0087-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800091001, Sterile, LD0692A - 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
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0103-2016·2015-10-14
Resource Optimization & Innovation Recalls 37 Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 37 sterile open heart surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800569001, Sterile, CV0659A - 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 su
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0083-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 880330, Sterile, OR0761 - Total Hip - 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-0040-2016·2015-10-14
FDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 296 sterile surgical kits because an equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800418, Sterile, GY0487 - Major Vaginal 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 sur
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0064-2016·2015-10-14
Resource Optimization & Innovation Recalls 872 Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 872 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800558, Sterile, OR0647 - Extremity - 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-0067-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Neurosurgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 181 neurosurgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800562, Sterile, NU0651 - Neuro - 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 proced
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0063-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 416 sterile C-section surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800557, Sterile, LD0646 - 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-0065-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Head and Neck Surgical Kits
Resource Optimization & Innovation LLC is recalling 381 sterile Head & Neck surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800559, Sterile, ET0648 - Head & Neck - 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-0062-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Cardiac Catheterization Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric cardiac catheterization surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - 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
HighFDA (Devices)·Z-0055-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Abdominal Surgical Kits
Resource Optimization & Innovation LLC is recalling 712 sterile abdominal surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800546, Sterile, GS0635 - Abdominal - 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-0047-2016·2015-10-14
Resource Optimization & Innovation Recalls 840 Sterile Surgical Extremity Packs
Resource Optimization & Innovation LLC is recalling 840 sterile surgical extremity packs because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800525, Sterile, OR0609 - Extremity 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 surgic
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0101-2016·2015-10-14
Resource Optimization & Innovation Recalls Robotic Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 30 sterile robotic hysterectomy surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number 800567001, Sterile, GY0656A - 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 durin
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0043-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile AV Access Surgical Kits
Resource Optimization & Innovation LLC is recalling 192 sterile AV Access surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn 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-0035-2016·2015-10-14
Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800413, Sterile, CV0482 - 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 surgical
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0031-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 600 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800408, Sterile, LD0477 - C-Section 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-0042-2016·2015-10-14
Resource Optimization & Innovation Recalls 124 Sterile Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 124 sterile arthroscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy 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-0032-2016·2015-10-14
FDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 3,099 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800409, Sterile, GS0478 - 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-0036-2016·2015-10-14
Resource Optimization & Innovation Recalls 874 Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 874 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800414, Sterile, OR0483 - Total Joint 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-0053-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,144 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800533, Sterile, GS0606 - Abdominal 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-0071-2016·2015-10-14
Resource Optimization & Innovation Recalls 158 Sterile Titanium Rib Surgical Kits
Resource Optimization & Innovation LLC is recalling 158 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800568, Sterile, OR0658 - 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 surgical
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2825-2015·2015-10-07
Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
Product
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2807-2015·2015-09-30
Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures
Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.
Product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for end
Category
Medical Device
Distribution
Distributed nationwide