Recall record at a glance
| Official record | Z-1876-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medline Industries, LP |
| Report date | Apr 29, 2026 |
| Recall initiation date | Feb 27, 2026 |
| Quantity | 270,311 total |
| Location | Northfield, IL, United States |
Official product description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A
Why the product was recalled
Unapproved design changes to the products outside of the 510(k) clearance.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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