Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,438
Critical: 25
Severe: 993
Most recent: 2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

751–775 of 3438

HighFDA (Devices)·Z-1716-2022·2022-09-21
Roadrunner UniGlide wire guide recalled for potential sterility compromise
Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2022·2022-09-21
Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2022·2022-09-21
Vascular Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1717-2022·2022-09-21
Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2022·2022-09-21
Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise
Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1524-2022·2022-09-21
Injectable Steroid Product Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.
Product
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2022·2022-09-21
Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1534-2022·2022-09-21
FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure
Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.
Product
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1519-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.
Product
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1527-2022·2022-09-21
TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.
Product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1692-2022·2022-09-14
PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles
American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
Product
Various PICC Line, Central Line Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1689-2022·2022-09-14
Angiography Packs Recalled Due to Sterilization Validation Failure
American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.
Product
Various Angiography packs/trays
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1697-2022·2022-09-14
Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation
American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.
Product
Breast Abdominoplasty Pack
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1677-2022·2022-09-14
CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging
Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.
Product
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2022·2022-09-14
Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
Product
Various ob/gyn packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1699-2022·2022-09-14
Surgical instrument convenience packs recalled for inadequate sterilization validation
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
Product
Various convenience packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1690-2022·2022-09-14
Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
Product
Various Angiography/Cath Lab packs/trays
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1683-2022·2022-09-14
Medline Chest Tube Kit Recalled for Non-Sterile Tape Component
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
Product
Medline CHEST TUBE REORDER NO: DYNJ36762A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1695-2022·2022-09-14
Cysto Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Product
Various Cysto Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1559-2022·2022-08-31
EVIS EXERA III Bronchovideoscope Recalled Due to Veterinary Use Before Clinical Assignment
An EVIS EXERA III Bronchovideoscope was recalled after being used in a veterinary endoscopy procedure before assignment to healthcare facilities. The device presents a potential contamination risk.
Product
EVIS EXERA III Bronchovideoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1552-2022·2022-08-24
FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier
Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.
Product
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1553-2022·2022-08-24
Surgical forceps recalled due to compromised sterile barrier
Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.
Product
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1251-2022·2022-07-27
Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1252-2022·2022-07-27
Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Fentanyl Citrate Injection nationwide due to lack of assurance of sterility. Approximately 9,410 bags distributed to healthcare facilities are affected.
Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Category
Drug
Distribution
Distributed nationwide