Z-0189-2027 Class II Ongoing
FDA device recall Z-0189-2027 was initiated by Medline Industries, LP on Sep 11, 2026 and is designated Class II. Reason for recall: Discrepancy in the shelf-life of a component The recall status is ongoing. Affected quantity: 30 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Sep 11, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 kits
Product Description
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Reason for Recall
Discrepancy in the shelf-life of a component
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0189-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026