Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.. 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: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
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
Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 26BBA206; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25LBQ023; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25KBR149; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25EBF588; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25ABI296; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 24IBP190; Medline Product Number/SKU DYNJ0538615J; UDI/DI 10195327673376 (each) 40195327673377 (case), Lot number 24DBC864.
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-0175-2027 |
| 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 | 235 kits |
More recalls from Medline Industries, LP · all medical device recalls · recalls from September 2026