Medline surgical convenience kits labeled as: OPEN HEART recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D. Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
What is being recalled
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Why
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0178-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 2, 2026 |
| Reported | October 21, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 165 kits |
More recalls from Medline Industries, LP · all medical device recalls · recalls from September 2026