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.

1726–1750 of 2228

HighFDA (Devices)·Z-0083-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 880330, Sterile, OR0761 - Total Hip - 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-0079-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 72 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 880323, Sterile, LD0754 - 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-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-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 pr
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 surgical
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 surgi
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 surgical
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 pro
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 p
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0086-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 388 sterile C Section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800036003, Sterile, LD0274C - 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-0050-2016·2015-10-14
Resource Optimization & Innovation Recalls 516 Sterile Lap Chole Surgical Kits
Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800528, Sterile, GS0612 - 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 surgica
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 surgi
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 surgical
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2825-2015·2015-10-07
Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
Product
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2793-2015·2015-09-30
Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects
Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.
Product
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-1679-2015·2015-09-23
FDA Recalls Compounded Intrathecal Pain Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because FDA inspections found violations that may have compromised the product's sterility.
Product
Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1669-2015·2015-09-23
FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone, Clonidine, and Baclofen intrathecal solution because FDA inspections found GMP violations that may have compromised sterility.
Product
Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1707-2015·2015-09-23
FDA Recalls Compounded Sterile Morphine, Fentanyl, and Bupivacaine Solution
The Compounding Pharmacy of America is recalling a sterile compounded solution of morphine, fentanyl, and bupivacaine due to GMP violations that compromise sterility assurance.
Product
Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2772-2015·2015-09-23
Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2537-2015·2015-09-09
Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns
Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acces
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2536-2015·2015-09-09
MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Product
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2527-2015·2015-09-09
Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2533-2015·2015-09-09
Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.
Product
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acce
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2535-2015·2015-09-09
MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2526-2015·2015-09-09
Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascul
Category
Medical Device
Distribution
Distributed nationwide