Stryker Instruments Div. of Stryker Corporation Stryker CBCII with 3/16 in. Silicone Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S16. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker CBCII with 3/16 in. Silicone Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S16. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
serial number 07317012 through 09192012.
Products Sold
serial number 07317012 through 09192012.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker CBCII with 3/16 in. Silicone Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-02 due to The product may not be sterile due to package not being intact.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product may not be sterile due to package not being intact.
Recommended Action
Per FDA guidance
Stryker issued a "Medical Device Recall Notification" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm. For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808.
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 noticePage updated: Jan 10, 2026