Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

1701–1725 of 2228

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-0114-2016·2015-10-14
Stryker Recalls Disposable Paper Filters for Sterilization Containers
Stryker is recalling disposable paper filters for sterilization containers because inhomogeneous paper may compromise the sterile barrier during shelf-life.
Product
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Category
Medical Device
Distribution
0 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
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-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-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-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