Z-3095-2024 Class II Ongoing
FDA device recall Z-3095-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 7, 2024 and is designated Class II. Reason for recall: Potential for an incomplete seal on the packaging tray. The recall status is ongoing. Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- May 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Reason for Recall
Potential for an incomplete seal on the packaging tray.
Distribution Pattern
US Nationwide distribution.
Code Information
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3095-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026