Class II Recall

MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/

Summary

The FDA issued a Class II for MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit by Medline Industries, LP. Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irr.

Details

Source

Device Recall

External ID

Z-2507-2026

Action Date

2026-06-24

Status

Ongoing

Product Description

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.

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), 40198459086992 (case), Lot Number 24IBI407; Medline Kit Number/SKU CDS983775L: UDI/DI 10198459518416 (each), 40198459518417 (case), Lot Number 25LBA083; Medline Kit Number/SKU CDS983775L: UDI/DI 10198459518416 (each), 40198459518417 (case), Lot Number 25LBA639; Medline Kit Number/SKU CDS983775L: UDI/DI 10198459518416 (each), 40198459518417 (case), Lot Number 25KBG543; Medline Kit Number/SKU CDS983775L: UDI/DI 10198459518416 (each), 40198459518417 (case), Lot Number 25KBB188; Medline Kit Number/SKU CDS983775L: UDI/DI 10198459518416 (each), 40198459518417 (case), Lot Number 25JBH879; Medline Kit Number/SKU CDS983775M: UDI/DI 10198459658358 (each), 40198459658359 (case), Lot Number 26CBF631; Medline Kit Number/SKU DYNJ84480: UDI/DI 10195327370121 (each), 40195327370122 (case), Lot Number 23LBU479; Medline Kit Number/SKU DYNJ84480: UDI/DI 10195327370121 (each), 40195327370122 (case), Lot Number 23JBY640; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 22LDB219; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 22GDB372; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 22CDA529; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 21LDC134; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 21KDA904; Medline Kit Number/SKU DYNJVB1080: UDI/DI 10193489284492 (each), 40193489284493 (case), Lot Number 21JDA634; Medline Kit Number/SKU DYNJVB1080A: UDI/DI 10195327325695 (each), 40195327325696 (case), Lot Number 23IDA988; Medline Kit Number/SKU DYNJVB1080A: UDI/DI 10195327325695 (each), 40195327325696 (case), Lot Number 23HDA236; Medline Kit Number/SKU DYNJVB1080A: UDI/DI 10195327325695 (each), 40195327325696 (case), Lot Number 23CDB306.

Quantity Affected: 2340 units

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-04

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2507-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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