Z-0628-2025 Class II Ongoing
FDA device recall Z-0628-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 9, 2024 and is designated Class II. Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. The recall status is ongoing. Affected quantity: 944 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2024
- Initiation Date
- Oct 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 944 units
Product Description
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
Code Information
1) REF DYNJ52404I, UDI/DI 10195327339159 (each) 40195327339150 (case), Lot Numbers: 23HDB384, 23IDC338; 2) REF DYNJ59073B, UDI/DI 10195327200398 (each) 40195327200399 (case), Lot Numbers: 23CBG401, 22JBI913, 23GBU324, 23EBL522, 23BBA464, 23CBU743, 23IBS781; 3) REF DYNJ80226A, UDI/DI 10195327195021 (each) 40195327195022 (case), Lot Numbers: 22GBV225, 22FBV173, 22FBV174; 4) REF DYNJ83140, UDI/DI 10195327232955 (each) 40195327232956 (case), Lot Numbers: 22JBN386
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0628-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026