Reported May 20, 2026 · Ongoing

1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART…

Medline Industries, LP

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

295 of 295 products

Products covered by this recall
Model / numberBarcodesProduct as published
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91637
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91667
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 92995
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 95615
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 97091
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 102177
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 104282
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 108922
600101951019348904023430193489040238Medline Kit Number/ : UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 110250
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 89290
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 91926
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 98742
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 100867
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 103336
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 112524
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 120251
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 123676
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 126203
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 133960
600104681019348904031930193489040313Medline Kit Number/ : UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 135744
Amount recalled
567675 kits

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide
  • CA

Why it was recalled

Stop using this product now

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.