Hsmg, Inc. D/b/a Smartinfuser Usa SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
Brand
Hsmg, Inc. D/b/a Smartinfuser Usa
Lot Codes / Batch Numbers
All models and lot codes received 1/1/2007 to 1/22/2009. Part numbers P49524, P49534, P49624, and P49634.
Products Sold
All models and lot codes received 1/1/2007 to 1/22/2009. Part numbers P49524, P49534, P49624, and P49634.
Hsmg, Inc. D/b/a Smartinfuser Usa is recalling SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. due to Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
Recommended Action
Per FDA guidance
SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
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