Recall record at a glance
| Official record | Z-1562-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medline Industries, LP |
| Report date | Mar 18, 2026 |
| Recall initiation date | Jan 30, 2026 |
| Quantity | 2894 units |
| Location | Northfield, IL, United States |
Official product description
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
Why the product was recalled
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Distribution information
Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.
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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