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.

2651–2675 of 3429

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 su
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0104-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 sterile Open Heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 880327002, sterile, CV0758B - 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 s
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0038-2016·2015-10-14
FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 324 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - 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 duri
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 pro
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0044-2016·2015-10-14
FDA Recalls 146 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 146 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800508, Sterile, LD0586 - 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-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 surgica
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 surgical
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 surg
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 sur
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 s
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0030-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800407, Sterile, OR0476 - 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 pr
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0073-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 24 sterile surgical kits because a component may have splits or holes that compromise sterility.
Product
regard Item Number: 800597, Sterile, GY0688 - LAVH - 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 procedu
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0054-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 144 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800535, Sterile, LD0620 - 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-0034-2016·2015-10-14
FDA Recalls Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 904 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411, Sterile, NU0480 - 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 pro
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-0066-2016·2015-10-14
FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800560, Sterile, GS0649 - 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-0049-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 92 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder 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-0056-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile Extremity Surgical Kits
Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800548, Sterile, OR0637 - 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-0099-2016·2015-10-14
FDA Recalls 88 Sterile Lap Chole Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 88 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800560001, Sterile, GS0649A - 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
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0089-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,400 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800408001, Sterile, LD0477A - 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 surg
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0094-2016·2015-10-14
Resource Optimization & Innovation Recalls 164 Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 164 arthroscopy surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800422001, Sterile, OR0491A - 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 sur
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0096-2016·2015-10-14
FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800528001, Sterile, GS0612A - 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 surgi
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0061-2016·2015-10-14
FDA Recalls Pediatric Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 746 sterile pediatric surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800554, Sterile, GS0643 - 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 surgi
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 p
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0085-2016·2015-10-14
FDA Recalls 658 Sterile Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 658 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800036002, Sterile, LD0274B - 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