CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
Medline Medical Procedure Kits labeled as recalled by Medline Industries
Medline Industries is recalling Medline Medical Procedure Kits labeled as: Retina Lac/Usc Cds, Medline Kit Number, distributed nationwide in the US. The recall was initiated on 4 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2507-2026
- FDA event ID
- 98994
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 May 2026
- FDA classified
- 17 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 May 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +44 days |
| 24 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
24 other products · FDA event 98994This product is part of a recall event; the main page for the event is Medline Medical Procedure Kits labeled as: Basic Heart Pack recalled.
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