Medline Industries, LP: Device Recall

Recall Details

Recall Number

Z-1035-2026

Classification

Class II

Product Type

Device

Recalling Firm

Medline Industries, LP

Status

Ongoing

Date Initiated

11/21/2025

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,611,081 eaches

Reason for Recall

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

Product Description

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.

Other Recalls by Medline Industries, LP

• Class II: Risk 12/16/2025
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
• Class II: Risk 12/16/2025
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
• Class II: Risk 12/16/2025
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
• Class II: Risk 12/16/2025
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
• Class II: Risk 12/16/2025
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

View all recalls by Medline Industries, LP →