FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID recall
- Recall number
- Z-0628-2025
- Date
- (initiated October 9, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 944 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0628-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.