FDA Medical devices recall ·
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code:… recall
- Recall number
- Z-2941-2026
- Date
- (initiated June 16, 2026)
- Company / brand
- Bd Switzerland Sarl
Terre Bonne Park A4, Eysins, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 93,700
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.
Why was it recalled?
Products may not have received adequate sterilization processing.
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
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 Lot Number: 26025260 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 Lot Number: 26035455 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Lot Number: 26055528
Distribution
U.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA O.U.S.: Canada
States: Arizona California Colorado Florida Georgia Illinois Indiana Kansas Maryland Michigan Minnesota Missouri Mississippi North Carolina Nevada New York Ohio Oklahoma Oregon Pennsylvania South Dakota Tennessee Texas Utah Virginia Washington
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-2941-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.