Medline procedure kits labeled as recallZ-1463-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
Recall details
- Recall number
- Z-1463-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2025
- Posted by the FDA
- Mar 26, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1152 units
- Product code
- KDD
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Code information (models, lots, serial numbers)
1) Pack Number DYNJ60655D: UDI/DI 10195327464783 (each), 40195327464784 (case), Lot Number 24AMC692A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ60655DMedline Industries, Inc. · Cardiac catheterization kit2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96373).
- Z-1461-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DY…
- Z-1462-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4…
- Z-1464-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941;…
- Z-1465-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) A…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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