Merit Medical Systems, Inc Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00
Brand
Merit Medical Systems, Inc
Lot Codes / Batch Numbers
Lot # A286536 # A286573 #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538 #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616 #A284618, #A286535, #A286547, #A284998 #A284694, #A284617, #A286560, #A286542 #A286550, #A287554, #A287553, #A279791 #A290033, #A290053, #A286541, and #A283067.
Products Sold
Lot # A286536 # A286573 #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538 #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616 #A284618, #A286535, #A286547, #A284998 #A284694, #A284617, #A286560, #A286542 #A286550, #A287554, #A287553, #A279791 #A290033, #A290053, #A286541, and #A283067.
Merit Medical Systems, Inc is recalling Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if packag due to There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
Recommended Action
Per FDA guidance
Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.
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