FDA recall, , Moderate risk
BD Intravascular Administration and Extension Sets
Intravascular administration sets may not have received adequate sterilization processing.
Summary by Recall Canary from the FDA notice
What happened
BD SWITZERLAND SARL of Eysins, Switzerland, began a recall on June 16, 2026, for certain intravascular administration and extension sets used to administer fluids, including the 60 In Non-DEHP Minibore Extension Set RES ME2010, MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C, and 9 IN Extension Set w/Max Y REF MPX5300-C. The recall was added to the FDA's Enforcement Report and classified on August 13, 2026.
Due to a mechanical issue with internal sterilization equipment, the products may not have received adequate sterilization processing, potentially resulting in underdosing during processing.
The products were distributed in the U.S. states of 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 and Washington, and in Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Match the lot code and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
60 In Non-DEHP Minibore Extension Set RES ME2010
- UDI-DI
- 10885403236235
- Lot code
- 26025260
- 26035455
- 26055528
MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C
- UDI-DI
- 10885403274619
- Lot code
- 26025260
- 26035455
- 26055528
9 IN Extension Set w/Max Y REF MPX5300-C
- UDI-DI
- 10885403237218
- Lot code
- 26025260
- 26035455
- 26055528
Recall details
- Company began the recall
- Sold in
U.S.: 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 O.U.S.: Canada
- Company
- BD SWITZERLAND SARLEysins, Switzerland
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99264
- Recall number
- Z-2941-2026
All recalls from BD SWITZERLAND SARL
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
