Z-0178-2027 Class II Ongoing
FDA device recall Z-0178-2027 was initiated by Medline Industries, LP on Sep 2, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 165 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Sep 2, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 kits
Product Description
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0178-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026