CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report

Non-DEHP Minibore Extension Set RES ME2010 recalled

BD Switzerland Sarl is recalling Non-DEHP Minibore Extension Set RES ME2010, distributed in 26 states. The recall was initiated on 16 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes60 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

Quantity recalled93,700

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2941-2026
FDA event ID: 99264
Recalling firm: BD Switzerland Sarl, Eysins
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2026
FDA classified: 13 Aug 2026
Reported: 19 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

16 Jun 2026	Recall initiated by company
13 Aug 2026	Classified by FDA	+58 days
19 Aug 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products may not have received adequate sterilization processing.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Arizona California Colorado Florida Georgia Illinois Indiana Kansas Maryland Michigan Minnesota Missouri Mississippi North Carolina Nevada New York Ohio Oklahoma Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Products may not have received adequate sterilization processing.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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