FDA-Device2026-05-20Class IPROCESSING DEFECT

Medline Namic Preceptor blood pressure manifold recalled for particulate contamination

OTHERNationwide distributionMedical devices

What this means

Medline has identified particulate matter inside the fluid pathway of certain Namic Preceptor Manifold blood pressure transducers. This contamination could affect the accuracy of blood pressure readings or damage the device during use. No injuries have been reported to date.

  • Check if your device matches one of the affected lot numbers: 117277, 119982, 122210, 122199, 130129, 133014, 136396, 138613, 139138, 157974, 162399, 164317, 175538, 193515, or 193531.
  • Stop using the affected manifold immediately.
  • Contact Medline customer service or your healthcare facility for instructions on replacement or return.
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The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
760 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2142-2026

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