Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
Lot Numbers: 08239012, 08254012 and 08297012.
Products Sold
Lot Numbers: 08239012, 08254012 and 08297012.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stry due to An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
Recommended Action
Per FDA guidance
A "Medical Device Recall Notification" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the "Business Reply Form" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762. Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WV, WI, WY
Page updated: Jan 10, 2026