The Recall Desk
HighFDA (Devices)·Z-2507-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377

Pending LLM rewrite. Source: FDA_DEVICE Z-2507-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

The recalled product

Product
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377
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)

  • Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each)
  • 40193489980661 (case)
  • Lot Number 24BBF438
  • Lot Number 23LBR516
  • Lot Number 23LBI385
  • Lot Number 23GBW083
  • Lot Number 23GBT137
  • Lot Number 23GBA705
  • Lot Number 23EBT206
  • Lot Number 23BBN853
  • Lot Number 23BBG437
  • Lot Number 23BBG444
  • Lot Number 23BBA852
  • Lot Number 23BBA859
  • Lot Number 22IBR361
  • Lot Number 22IBF066
  • Lot Number 22GBA053
  • Lot Number 22GBA052
  • Lot Number 22GBA054
  • Lot Number 22DBM893

Distribution

Distributed nationwide across the United States.

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