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Medline Chest Drainage Units Recall Updated IFUs for Adults 18+

Medline Industries recalls 2,894 Aqua-Seal Chest Drainage Units from Cardinal Health after updating IFUs to specify adult patients 18 years and older. The devices were distributed worldwide, including California, Chile and Panama. The update clarifies intended patient population and requires action from healthcare providers to stop use until further notice.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 30, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 30, 2026
Hazard Level
HIGH
Brands
Medline Industries, LP, Cardinal Health, Medline
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP, Cardinal Health, Medline
Product type
Chest Drainage Unit
Model numbers
DYNJ902487A, DYNJ908126, DYNJ910851
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 30, 2026

  2. Reported by FDA DEVICE

    March 18, 2026

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

About This Product

Chest drainage units are used in surgical settings to remove air and fluids from the chest. They support post-operative care in cardiac procedures.

Why This Is Dangerous

The recall centers on clarified adult-only target population in the device IFUs. This affects labeling and may influence patient selection and usage.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Facilities must stop use for affected units and verify alignment with updated IFUs. No injuries reported in the notice, but operational disruption and potential documentation burden exist.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers against DYNJ902487A, DYNJ908126, DYNJ910851
  2. Review attached lot numbers: 22KMG297, 22FMA481, 21IMG797, 21HMG569, 21HMB801
  3. Compare IFU language to confirm 18+ adult target population

Where to find product info

FDA recall page linked in enforcement report and Medline recall communications

What timeline to expect

Processing and remediation timelines vary by facility; 4-8 weeks is a common framework

If the manufacturer is unresponsive

  • Escalate to hospital compliance department
  • Contact Medline customer service for escalation
  • Document all communications

How to prevent similar issues

  • Verify labeling updates before procurement
  • Request updated IFUs with new adult-target guidance
  • Maintain device inventory with recall identifiers

Documentation advice

Keep copies of recall notices, model/lot numbers, correspondence with Medline and facility records

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Product Details

Product: Aqua-Seal Chest Drainage Unit. Brand: Cardinal Health via Medline Industries, LP. Models: DYNJ902487A; DYNJ908126; DYNJ910851. UDI-DI: 10193489496635. Lot numbers include 22KMG297, 22FMA481, 21IMG797, 21HMG569, 21HMB801. Quantity: 2894 units. Distribution: Worldwide, including United States (California), Chile, Panama.

Reported Incidents

No injuries or incidents are described in the provided notice.

Key Facts

  • 2894 units recalled worldwide
  • Models: DYNJ902487A, DYNJ908126, DYNJ910851
  • Lot numbers: 22KMG297, 22FMA481, 21IMG797, 21HMG569, 21HMB801
  • IFUs updated to specify adults 18 years and older
  • CA state distribution included

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANT
Injury Types
ELECTRICALLACERATION

Product Details

Model Numbers
DYNJ902487A
DYNJ908126
DYNJ910851
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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