MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98...
FDA Device Recall #Z-2507-2026 - Class II, May 4, 2026
Recall Summary
| Recall Number | Z-2507-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 4, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 2340 units |
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.
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 Pattern
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot / Code Information
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.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2790-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2788-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2791-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2789-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bo... | Jun 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.