Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,235
Critical: 4
Severe: 260
Most recent: 2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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.

1676–1700 of 2235

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-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…
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…
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-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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0098-2016·2015-10-14
Resource Optimization & Innovation Recalls Pediatric Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 158 pediatric surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800554002, Sterile, GS0643B - 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-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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0069-2016·2015-10-14
FDA Recalls VP Shunt Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 200 VP Shunt surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 800566, Sterile, NU0655 - VP Shunt - 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-0091-2016·2015-10-14
FDA Recalls 510 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 510 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411001, Sterile, NU0480A - 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…
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…
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…
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-0100-2016·2015-10-14
FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number 800565001, Sterile, CV0654A - 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…
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-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