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.

151–175 of 1010

HighFDA (Devices)·Z-1963-2025·2025-06-18
Microtek Patient Drape Adapter Kits Recalled for Non-Sterile Labeling
Microtek Medical recalls patient drape adapter kits labeled as sterile that are non-sterile, creating infection risk in medical procedures. The recall affects 2,024 boxes distributed across multiple U.S. states.
Product
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1953-2025·2025-06-18
Ophthalmic surgical knives recalled due to sterility assurance concerns
Tecfen Medical is recalling 38 units of MVR Sideport Knives (Model QKN2312) due to sterility assurance concerns. The surgical instruments used in eye procedures may pose an infection risk if sterility cannot be assured.
Product
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2025·2025-06-18
Ophthalmic knives recalled due to sterility assurance concerns
Tecfen Medical is recalling 92 units of 2.2mm Slit Knife, Angled (Model QKN2261) due to sterility assurance concerns. The devices were distributed worldwide.
Product
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2025·2025-06-18
Contact Lens Insertion Solution Recall Due to Sterility Defect
Contamac Nutrifill contact lens insertion solution may lack sterility, creating an infection risk. Affected lots HFH, HGC, HGI, HGN, HKF, HKK distributed nationwide should not be used.
Product
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2025·2025-06-11
Olympus Duodenovideoscope Recalled Due to Increased Microbial Contamination
Olympus Corporation recalls approximately 12,195 EVIS EXERA III Duodenovideoscopes (Model TJF-Q190V) worldwide. Post-market surveillance data suggests higher microbial contamination levels when manual cleaning is delayed beyond one hour and a presoak is performed.
Product
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2025·2025-06-11
Palindrome Precision HSI Hemodialysis Catheter Recalled for Sterile Barrier Breach
Mozarc Medical is recalling the Palindrome Precision HSI Chronic Hemodialysis Catheter due to potential breaches in sterile barrier packaging. Affected units may pose infection risk if the barrier has been compromised.
Product
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2025·2025-06-11
MAHURKAR Chronic Hemodialysis Catheter recalled for sterile barrier packaging breach
Mozarc Medical US LLC is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack due to a potential breach of sterile barrier packaging. The breach could allow contamination of the catheter, creating infection risk.
Product
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2025·2025-06-04
Cardinal Health Umbilical Catheters Recalled for Packaging Sterility Defect
Cardinal Health is recalling 10,438 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Product
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2025·2025-06-04
Umbilical Vessel Catheters Recalled Due to Sterility Packaging Defect
Cardinal Health recalls 1,710 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile devices could cause infection in newborns.
Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2025·2025-06-04
Umbilical vessel catheters recalled due to packaging defect compromising sterility
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters used on neonates could cause infection.
Product
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2025·2025-06-04
Umbilical Catheter Insertion Tray Recall Due to Packaging Defect Risk
Cardinal Health is recalling 370 units of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility, posing infection risk to neonates.
Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2025·2025-06-04
Umbilical Vessel Catheters Recalled for Sterility-Compromising Packaging Defect
Cardinal Health is recalling 51,378 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in newborns.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2025·2025-06-04
Umbilical vessel catheter recalled due to packaging sterility defect
Cardinal Health is recalling 2,280 umbilical vessel catheters due to a packaging defect that may compromise product sterility. Non-sterile catheters could cause infection in neonates.
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2025·2025-06-04
Ethos Collar Stem Orthopedic Implants Recalled for Sterility Seal Breach
Onkos Surgical is recalling 233 Ethos Collar Stem implants due to potential breaches in sterility-assurance seals. The affected units were distributed across 18 states and could contaminate orthopedic implants if the seals are compromised.
Product
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1732-2025·2025-05-14
B Braun Coaxial Dilator Kits Recalled for Potential Sterile Barrier Seal Failure
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to potential open seals in the sterile barrier packaging, which may compromise device sterility.
Product
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2025·2025-05-14
Medical Introducer System Recalled for Potential Compromised Sterile Packaging
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System due to a potential open seal in the sterile barrier packaging, which could compromise sterility. Approximately 100 systems are affected.
Product
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2025·2025-05-14
Eye Lubricant Solution Recalled for Manufacturing Deviations and Sterility Concerns
BRS Analytical Services is recalling Carboxymethylcellulose Sodium 0.5% ophthalmic solution nationwide due to manufacturing practice deviations and inability to assure sterility. Multiple lot numbers are affected.
Product
CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2025·2025-05-14
Galt Centeze Catheter recalled for potential sterile barrier packaging defect
Galt Medical Corporation is recalling Centeze Catheters due to a potential open seal in sterile packaging. Affected catheters were distributed nationwide and internationally.
Product
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0374-2025·2025-04-30
Rocuronium Bromide Syringes Recalled for Sterility Assurance Issue
Denver Solutions recalls 16,655 Rocuronium Bromide syringes nationwide due to damaged or leaking units that compromise sterility assurance. Lot #2530023 expires 7/12/2025.
Product
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1528-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters due to lack of sterility assurance, which poses a serious infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1524-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling 9,020 units of Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The affected devices were distributed worldwide and may pose an infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1525-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 2080 units of Ballard Closed Suction Catheters (Model 2210-5) due to lack of sterility assurance, an FDA Class I recall affecting users worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1527-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling 1,040 Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. These devices are used for airway suctioning in adults.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1522-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 4,000 units of Ballard Closed Suction Catheters Model 210 used in neonatal and pediatric care due to lack of sterility assurance. The recall affects devices distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1523-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical is recalling 9,960 units of Ballard Closed Suction Catheters (Model 20083) used in neonatal and pediatric care due to lack of sterility assurance. Products may not be properly sterilized, creating infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide