The Recall Desk
Severity pendingFDA (Devices)·Z-1394-2026·Announced 2026-02-25

Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLE

Pending LLM rewrite. Source: FDA_DEVICE Z-1394-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

The recalled product

Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) CDS983069G
  • UDI-DI: 10193489923926(each)
  • 40193489923927(case)
  • Lot Number: 21IBD399
  • 2) CDS983069G
  • Lot Number: 21HBO921
  • 3) CDS983069I
  • UDI-DI: 10195327071868(each)
  • 40195327071869(case)
  • Lot Number: 22JBW315
  • 4) CDS983069I
  • Lot Number: 22GBE731
  • 5) CDS983069I
  • Lot Number: 22FBX804
  • 6) CDS983782C
  • UDI-DI: 10193489592047(each)
  • 40193489592048(case)
  • Lot Number: 21DKA756
  • 7) DYKE1456D
  • UDI-DI: 10195327639938(each)

Distribution

Distributed nationwide across the United States.

Related recalls

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