The Recall Desk

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.

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.

1651–1675 of 2228

  • SevereFDA (Devices)·Z-0188-2016·2015-11-04

    FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0185-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0190-2016·2015-11-04

    Resource Optimization Recalls 28 Custom Cardiovascular Surgical Kits

    Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0189-2016·2015-11-04

    FDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance

    Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0187-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0186-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.

    Product
    Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0158-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,246 units of the MOSAICPLASTY DP Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0033-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800410, Sterile, CV0479 - 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 surgic
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0092-2016·2015-10-14

    FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411002, Sterile, NU0480B - 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
  • SevereFDA (Devices)·Z-0074-2016·2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - 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
  • 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-0075-2016·2015-10-14

    FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - 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
  • SevereFDA (Devices)·Z-0082-2016·2015-10-14

    FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880328, Sterile, HT0759 - Pacemaker 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
  • SevereFDA (Devices)·Z-0059-2016·2015-10-14

    FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800551, Sterile, GS0640 - 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
  • SevereFDA (Devices)·Z-0052-2016·2015-10-14

    Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800532, Sterile, GY0616 - Vaginal 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 s
    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 surgi
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0078-2016·2015-10-14

    FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proce
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0084-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits

    Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880331, Sterile, OR0762 - 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-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-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-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-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