FDA Medical devices recall ·
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 recall
- Recall number
- Z-1766-2025
- Date
- (initiated April 9, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 840 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Why was it recalled?
Three is the potential for the retractors to puncture through the sterile packaging.
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
UDI/DI 10653160287018 (each) 00653160287011 (case), Lot Numbers: 2020061990, 2020070990, 2020110490, 2020111090, 2021082590, 2021121490, 2022062890, 2022110190, 2022121990, 2023032290, 2023032390, 2023092590, 2024050790, 2024053090, 2024062490, 2024070190.
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-1766-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.