HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 5,314 IV Administration Sets on November 26, 2025. The recall affects several product SKUs due to potential failure of check valve components. Patients and healthcare providers should stop using these devices immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline kit SKU DYKM1980CUDI/DI 10195327608309 (EA) 40195327608300 (CS)Lot Number 25JBB147

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 26, 2025
Status
ACTIVE
Severity
7/10

Quick Facts at a Glance

Recall Date
November 26, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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
Product type
IV Administration Sets
Model numbers
Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25JBB147, Lot Number 25KBL305, Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25HBT834, Lot Number 25IBJ757 +6 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 26, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    April 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

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

IV Administration Sets are used in hospitals and outpatient settings for delivering medications and fluids intravenously. These kits are critical in medical treatments and are often used in emergency care and routine medical procedures.

Why This Is Dangerous

The malfunctioning check valve can lead to either a complete blockage or unintended flow of medication, which can compromise patient safety and treatment efficacy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may disrupt healthcare services temporarily, requiring healthcare providers to find alternative products quickly. This can lead to delays in patient care.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU number on your IV Administration Set package.
  2. Verify if your product matches any of the recalled SKUs: DYKM1980C, DYKM2137B, DYKS1372C, DYNDV1691B, DYNDV2464A.
  3. Inspect for lot numbers: 25JBB147, 25KBL305, 25HBT834, 25IBJ757, 25JBJ557, 25JLA480.

Where to find product info

The SKU and lot numbers are typically found on the product packaging or the label attached to the set.

What timeline to expect

Expect a refund or replacement process to take about 4-6 weeks after you initiate contact with Medline.

If the manufacturer is unresponsive

  • Follow up with Medline Industries via phone or email.
  • Document all communications in case further action is needed.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Stay informed about product safety through FDA notifications.
  • Choose products with clear safety certifications and labels.

Documentation advice

Keep copies of your purchase receipts, correspondence with the manufacturer, and any photos of the product as evidence.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled products include Medline kit SKUs DYKM1980C, DYKM2137B, DYKS1372C, DYNDV1691B, and DYNDV2464A. These kits were distributed nationwide in the U.S. and are classified as Class II. No price information is available.

Key Facts

  • Check valves may fail
  • Stop using immediately
  • Contact Medline for instructions
  • No injuries reported

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Medline kit SKU DYKM1980C
UDI/DI 10195327608309 (EA) 40195327608300 (CS)
Lot Number 25JBB147
Lot Number 25KBL305
Medline kit SKU DYKM2137B
+9 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

Related Recalls