Agency classClass IIOur severity:High FDA (Devices)·Z-0148-2025·Announced 2024-10-30

Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk

Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device used for respiratory care with a potential hazard of non-sterility. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' meriting a score of 3 (High).

Plain-English summary

Medline Industries is recalling certain Centurion PEDIATRIC/ADULT TRACHEOSTOMY T convenience kits (REF TC7895) with breather pouch lot number 323080002 due to a packaging defect.

According to the manufacturer, convenience kits packaged in the specified breather pouch lot may result in potential non-sterile product use if the vendor seal is opened or unsealed. For medical devices used in sensitive applications such as tracheostomy, non-sterility presents a potential risk.

The affected kits were distributed worldwide, including throughout the United States, Canada, and Panama. The recall involves approximately 30 units.

Affected patients, healthcare providers, and facilities should stop using affected kits and contact Medline Industries for replacement options. Healthcare providers should review their usage and distribution records for kits from the specified lot number.

The recalled product

Product: Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Respiratory / Airway Care
Hazard: non-sterile
infection-risk
Affected units: 30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

UDI/DI 40193489435246 (each)
10193489435245 (case)
Lot Numbers: 23LBM753
23KBD877

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 33 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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