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BD Intravascular Administration and Extension Sets
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MEDICAL DEVICE RECALLMODERATE

BD Intravascular Administration and Extension Sets

BD recalls IV administration and extension sets due to possible sterilization failure.

What to do

Stop using the affected products immediately and contact BD Switzerland Sarl for instructions on returning the devices and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2941-2026
Agency
FDA
Firm
BD SWITZERLAND SARL
Recall ID
99264
Status
ONGOING

Why it was recalled

BD Switzerland Sarl is recalling certain intravascular administration and extension sets due to a mechanical issue with internal sterilization equipment that may have resulted in underdosing of the sterilant, potentially leaving products not properly sterilized. The affected products include the 60 In Non-DEHP Minibore Extension Set RES ME2010, the MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C, and the 9 IN Extension Set w/Max Y REF MPX5300-C.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeUDI-DI
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.–10885403236235, 26025260, 10885403274619, 26035455, 10885403237218, 26055528
60 In Non-DEHP Minibore Extension Set RES ME201026025260, 26035455, 2605552810885403236235
MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C26025260, 26035455, 2605552810885403274619
9 IN Extension Set w/Max Y REF MPX5300-C26025260, 26035455, 2605552810885403237218

Where it was sold

Distributed in 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.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification