MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall Details

Recall Number

Z-0696-2025

Classification

Class II

Product Type

Device

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield

Status

Ongoing

Date Initiated

11/18/2024

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

360 uinits

Reason for Recall

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.

Product Description

HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

Distribution Pattern

US and Canada

Other Recalls by MEDLINE INDUSTRIES, LP - Northfield

• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class II: Risk 07/23/2025
  Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
• Class I: Dangerous 07/14/2025
  Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
• Class II: Risk 07/08/2025
  Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

View all recalls by MEDLINE INDUSTRIES, LP - Northfield →