Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

37451–37475 of 50506

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
HighFDA (Food)·F-0001-2016·2015-10-14
General Mills Recalls Cascadian Farm Frozen Cut Green Beans
General Mills is recalling a limited quantity of frozen Cascadian Farm Cut Green Beans after one package tested positive for Listeria monocytogenes.
Product
Cascadian Farm Organic Cut Green Beans, Net. Wt. 16 oz.
Category
Food
Distribution
Distributed nationwide
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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0039-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Laparoscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 400 sterile laparoscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy 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-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…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0028-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 26 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800091, Sterile, LD0692 - 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-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…
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…
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…
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…
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…
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…
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…
Category
Medical Device
Distribution
3 states