CLASS I ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

Namic Preceptor Manifold, custom, Medline Product Number recalled

Medline Industries is recalling Namic Preceptor Manifold, custom, Medline Product Number, distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI each 10193489059137, UDI/DI case 30193489059131, Lot Numbers: 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141.

Quantity recalled6390 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2141-2026
FDA event ID: 98735
Recalling firm: Medline Industries, Northfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 24 Mar 2026
FDA classified: 8 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

24 Mar 2026	Recall initiated by company
8 May 2026	Classified by FDA	+45 days
20 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

Where it was distributed

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Nationwide California

Questions about this recall

Is Namic Preceptor Manifold, custom, Medline Product Number recalled?

Yes. Medline Industries recalled Namic Preceptor Manifold, custom, Medline Product Number on 24 Mar 2026. The recall is Class I and its status is Ongoing. Recall number Z-2141-2026.

Why was it recalled?

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

Which lots are affected?

UDI/DI each 10193489059137, UDI/DI case 30193489059131, Lot Numbers: 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141.

Where was it sold?

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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