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.

3351–3375 of 3438

HighFDA (Devices)·Z-0852-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2013·2013-02-27
Medrad Hand Controller Sheath Recalled for Potential Sterility Breach
Medrad Inc is recalling Hand Controller Sheaths because a missing seal may compromise sterility. The product is used in cardiac catheterization procedures.
Product
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0826-2013·2013-02-27
ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals
ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.
Product
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2013·2013-02-27
Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2013·2013-02-06
Cordis ExoSeal Vascular Closure Device Recalled for Sterility Assurance Failure
Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.
Product
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Electrode Blades Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrode Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2013·2013-01-30
ConMed Recalls TUR Endoscopic Cables Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 TUR/Endoscopic Cables because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-110-2013·2013-01-09
FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
Product
Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-119-2013·2013-01-09
New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.
Product
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-118-2013·2013-01-09
New England Compounding Center Recalls Hyaluronidase Vials Due to Sterility Concerns
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.
Product
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2013·2012-11-28
King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect
King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.
Product
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2013·2012-11-28
King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.
Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0426-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0425-2013·2012-11-28
King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.
Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-054-2013·2012-11-21
Ameridose Recalls All Sterile Products Due to Sterility Assurance Concerns
Ameridose LLC is recalling all sterile products manufactured in Westborough, MA, due to a lack of assurance of sterility. The recall is nationwide and includes all lot codes within expiry.
Product
All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0258-2013·2012-11-14
Kimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects
Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.
Product
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0257-2013·2012-11-14
Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure
Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.
Product
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0205-2013·2012-11-14
Ormco Vector TAS Modular Driver Recalled for Incorrect Sterilization Instructions
Ormco/Sybronendo is recalling Vector TAS Modular Drivers because foreign language instructions list the wrong sterilization temperature.
Product
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0092-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0085-2013·2012-10-24
Osteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpans bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0087-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute…
Category
Medical Device
Distribution
Distributed nationwide