FDA Medical devices recall ·
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 recall
- Recall number
- Z-1514-2025
- Date
- (initiated March 7, 2025)
- Company / brand
- Ethicon Endo Surgery, LLC
475C - Suite 202, Guaynabo, PR, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,080 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Why was it recalled?
Identified curing issues with the silicone during the needles manufacturing process.
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
Product Code: Z127H-50; GMDN: 16584; UDI-DI: 10705031060227; Lot number: 104BQC;
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
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-1514-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.