Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Catalog Number / UDI-DI / Lot Numbers: BRC-BAL-INT-SL/B 00884450363102 T2581281 BRC-BAL-INT-SL/B 00884450363102 T2594451 BRC-BAL-INT-SL/B 00884450363102 T2606225 BRC-BAL-INT-SL/B 00884450363102 T2609782 BRC-BAL-INT-SL/B 00884450363102 T2628321 BRC-BAL-INT-SL/B 00884450363102 T2643945 BRC-BAL-INT-SL/B 00884450363102 T2685079 BRC-BAL-INT-SL/B 00884450363102 T2712303 BRC-BAL-INT-SL/B 00884450363102 T2745782 BRC-BAL-INT-SL/B 00884450363102 T2758208 BRC-BAL-INT-SL/B 00884450363102 T2800973 BRC-BAL-INT-SL/B 00884450363102 T2805964 BRC-BAL-INT-SL/B 00884450363102 T2846532 BRC-BAL-INT-SL/B 00884450363102 T2846539 BRC-BAL-INT-SL/B 00884450363102 T2850757 BRC-BAL-INT-SL/B 00884450363102 T2901641
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Recall record
- Recalling firm
- Merit Medical Systems, Inc.
- Product type
- Devices
- Recall number
- Z-2557-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- South Jordan, UT
- Recall initiated
- 2024-06-11
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2557-2024 · Source: openFDA enforcement.