Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as: 1) Retina LAC/USC CDS recall: During an internal review, Medline identified representative samples did

Recall published 4 months ago

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 hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2507-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
2340 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 24BBF438; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBR516; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBI385; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBW083; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBT137; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBA705; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23EBT206; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBN853; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBG437; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBG444; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBA852; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBA859; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22IBR361; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22IBF066; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA053; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA052; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA054; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22DBM893; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22DBS377; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22OBE639; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22ABB399; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22ABB400; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 24ABX491; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24GBG807; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24FBI951; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24EBH007; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25GMD344; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25EMG590; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25EMC381; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25CMJ064; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25CMC688; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25BMC192; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24KBS115; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24KBF283; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24JBD646; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24IBK663; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 4019845908…
UPC codes
10193489980660, 40193489980661, 10195327684761, 40195327684762, 10198459086991, 40198459086992

Products covered by this recall

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 CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.

Check your product

The notice names 34 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10193489980660
  • 40193489980661
  • 10195327684761
  • 40195327684762
  • 10198459086991
  • 40198459086992

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24BBF438
  • 23LBR516
  • 23LBI385
  • 23GBW083
  • 23GBT137
  • 23GBA705
  • 23EBT206
  • 23BBN853
  • 23BBG437
  • 23BBG444
  • 23BBA852
  • 23BBA859
  • 22IBR361
  • 22IBF066
  • 22GBA053
  • 22GBA052
  • 22GBA054
  • 22DBM893
  • 22DBS377
  • 22OBE639

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS983775I
  • CDS983775J
  • CDS983775K
  • CDS983775L
  • CDS983775M
  • DYNJ84480
  • DYNJVB1080
  • SKU CDS983775I

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489980660, 40193489980661, 10195327684761; lot code 24BBF438, 23LBR516, 23LBI385; model number CDS983775I, CDS983775J, CDS983775K. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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