Hazard

Infection Risk recalls

1,010 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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.

51–75 of 1010

HighFDA (Devices)·Z-1402-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Failure Risk
Medline is recalling 684 surgical convenience kits due to equipment calibration issues that may have compromised sterility assurance levels. Affected devices may not meet required sterilization standards.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline IV Administration and Extension Sets: Connector Defect Risk
Medline Industries is recalling 926,227 units of IV Administration and Extension Sets due to potential male luer connector defects that may leak, crack, or break during use, risking treatment delays, infection, blood loss, or air embolism.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 108 Convenience Kits nationwide due to sterilization equipment calibration defects that could compromise sterility assurance on medical closure devices.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2026·2026-02-25
Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline is recalling 82,597 surgical device kits nationwide due to equipment calibration issues that could affect sterilization quality. The kits were used in various surgical procedures.
Product
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
Medline PPE Convenience Kit Sterilization Calibration Issue Recall
Medline is recalling approximately 7,575 PPE Convenience Kits (Model DYK1011945P) due to sterilization equipment calibration issues that may compromise device sterility. Affected products were distributed nationwide.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2026·2026-02-25
Medline Surgical Kits Recalled for Potential Sterilization Compromise
Medline is recalling labor and delivery surgical kits due to calibration issues in sterilization equipment that could compromise product sterility. The recall affects 27,320 units distributed nationwide and worldwide.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1364-2026·2026-02-25
Medical device wound dressing recalled for potential sterile packaging barrier failures
Integra LifeSciences is recalling Medihoney Calcium Alginate wound dressings due to potential packaging failures that could breach the sterile barrier and increase infection risk.
Product
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2026·2026-02-25
Medline Surgical Device Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries, LP is recalling 9,051 surgical device kits due to sterilization equipment calibration issues that could compromise sterility assurance levels. The recalled kits may not be adequately sterile despite undergoing validated sterilization processes.
Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1419-2026·2026-02-25
Medical Device Surgical Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling 31 models of surgical instrument kits due to calibration issues with sterilization equipment that could affect sterility assurance. The recall affects approximately 7,725 units distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1320-2026·2026-02-18
Reprocessed diagnostic catheters recalled for residual material contamination
Medline Industries recalls reprocessed Abbott diagnostic catheters that may contain particles of residual material. Use could cause infection, inflammatory response, blood clots, or embolism.
Product
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0335-2026·2026-02-18
Thiamine HCl Injectable Solution Recalled for Lack of Sterility Assurance
Fresenius Kabi Compounding is recalling thiamine HCl injection (500 mg) due to lack of sterility assurance. The product was distributed nationwide.
Product
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1251-2026·2026-02-11
Tecfen Retractable Membrane Polisher recalled for sterile barrier defect
Vortex Surgical is recalling Tecfen Retractable Membrane Polishers due to potential voids in sterile pouches that could compromise the barrier and allow bioburden contamination. Approximately 8,651 units were distributed in the US.
Product
Tecfen Retractable Membrane Polisher, QTPR1267-23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2026·2026-02-11
Volk Single Use Vitrectomy Lenses Recalled for Compromised Sterile Barrier
Vortex Surgical Inc. is recalling Volk Single Use Vitrectomy Lenses due to voids in Tyvek pouch seals that could compromise the sterile barrier and lead to infection.
Product
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1247-2026·2026-02-11
Vortex Disposable Forceps and Cannula Surgical Instruments Recall
Vortex Surgical is recalling disposable forceps and cannulas due to voids in Tyvek pouch seals that could compromise sterile barriers and allow bioburden contamination, potentially leading to infection.
Product
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1253-2026·2026-02-11
Rumex Surgical Elevators Recalled for Compromised Sterile Barrier
Vortex Surgical Inc. is recalling Rumex Disposable Diamond Dusted ILM Elevators due to voids in sterilization pouch seals. The compromised barrier could allow contamination and lead to infection during surgical procedures.
Product
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2026·2026-02-11
Vortex Surgical Scleral Markers Recalled Due to Compromised Sterile Pouches
Vortex Surgical is recalling Lindsell Sutured IOL Marker scleral markers due to potential voids in sterile pouches. Compromised seals could allow bioburden contamination that may lead to infection.
Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2026·2026-02-11
Vortex Surgical 25GA Convenience Kits Recalled for Compromised Sterile Barriers
Vortex Surgical Inc. is recalling 25GA Convenience Kits due to potential voids in Tyvek pouch seals that could compromise sterility and lead to infection risk.
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1248-2026·2026-02-11
Subretinal Injection Cannulas Recalled for Compromised Sterile Seal
Vortex Surgical Inc. is recalling 25GA Subretinal Injection Cannulas due to voids in the sterile Tyvek pouches that could allow bioburden contamination and potentially lead to infection.
Product
25GA Subretinal Injection Cannula VS0220.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1252-2026·2026-02-11
Vortex Surgical I2 Injection Kit Recall: Potential Seal Defects
Vortex Surgical is recalling its I2 Injection Kits (model VS0500) due to potential voids in pouch seals that could compromise the sterile barrier and cause infection. Affected are 14,789 units distributed nationwide and internationally.
Product
Vortex Surgical I2 Injection Kit, VS0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1250-2026·2026-02-11
Vortex Surgical Internal Delivery Device Recalled for Compromised Sterile Barrier
Vortex Surgical is recalling its 25GA Internal Delivery Device due to voids in pouch seals that may compromise sterility, allowing potential bacterial contamination that could lead to infection.
Product
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2026·2026-01-28
Tego Needle-Free Connectors Recalled for Silicone Seal Separation Risk
ICU Medical is recalling Tego needle-free connectors used in hemodialysis and IV administration because the silicone seal may separate or tear, potentially causing fluid leaks, therapy delays, or exposure to harmful contaminants.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·26201·2026-01-22
Angry Orange Enzyme Stain Removers Recalled Due to Bacterial Contamination Risk
About 1.5 million Angry Orange Enzyme Stain Removers sold nationwide may contain Pseudomonas aeruginosa bacteria. The product poses a serious infection risk to people with weakened immune systems or underlying lung conditions.
Product
Angry Orange Enzyme Stain Removers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2026·2026-01-21
ThinPrep CytoLyt Solution Recalled for Fungal Contamination
Hologic has recalled ThinPrep CytoLyt Solution due to fungal contamination detected in one lot. The buffered cell wash solution may cause infection if used in diagnostic procedures.
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1006-2026·2026-01-07
Ultrasound probe covers recalled due to contamination defect risk
Sheathes3D ultrasound probe covers may have product defects allowing contamination during use, creating infection risk. Affected devices distributed nationwide in Washington state.
Product
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0939-2026·2025-12-31
Alcon Custom Pak ophthalmic surgical procedure packs recalled for incomplete seals
Alcon Custom Pak sterile ophthalmic surgical procedure packs may have incomplete seals compromising sterility. Affected units distributed in California, North Dakota, and Utah.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
Category
Medical Device
Distribution
Distributed nationwide