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.

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.

2651–2675 of 3438

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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0037-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 832 sterile shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800415, Sterile, OR0484 - Shoulder System 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…
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…
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-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…
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…
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…
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-0097-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Surgical Kits
Resource Optimization & Innovation LLC is recalling 136 sterile pediatric surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - 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
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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0095-2016·2015-10-14
FDA Recalls 230 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 230 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800524001, Sterile, LD0608A - 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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0113-2016·2015-10-14
Olympus MAJ-1606 Instrument Channel Adaptors Recalled for Sterility Breach
Olympus is recalling MAJ-1606 Instrument Channel Adaptors due to small puncture marks in sterile packaging that may compromise sterility.
Product
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Category
Medical Device
Distribution
Distributed nationwide
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…
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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0090-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 440 sterile open heart surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800410001, Sterile, CV0479A - 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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0048-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Head and Neck Surgical Kits
Resource Optimization & Innovation LLC is recalling 156 sterile surgical kits because a component may have splits or holes that compromise sterility.
Product
regard Item Number: 800526, Sterile, ET0610 - Head and 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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0060-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits
Resource Optimization & Innovation LLC is recalling 200 sterile total knee surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800553, Sterile, OR0642 - 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…
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…
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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0072-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 108 sterile open heart surgical kits because an equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800569, Sterile, CV0659 - 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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0076-2016·2015-10-14
FDA Recalls 164 Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 164 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800617, Sterile, NU0768 - Neuro 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-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…
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-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…
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…
Category
Medical Device
Distribution
3 states