[pending] Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-1562-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNJ902487A
- UDI-DI: 10193489496635(each)
- 40193489496636(case)
- Lot Number: 22KMG297
- 2) DYNJ902487A
- Lot Number: 22FMA481
- 3) DYNJ902487A
- Lot Number: 21IMG797
- 4) DYNJ902487A
- Lot Number: 21HMG569
- 5) DYNJ902487A
- Lot Number: 21HMB801
- 6) DYNJ908126
- UDI-DI: 10193489980110(each)
- 40193489980111(case)
- Lot Number: 26ABL637
- 7) DYNJ908126
- Lot Number: 25JBN467M
- 8) DYNJ908126
- Lot Number: 25JBN467
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27