Recall of Merit Medical's 16F Dual Valved Splittable Sheath Introducer
Merit Medical Systems, Inc. is recalling 368,264 units of its 16F Dual Valved Splittable Sheath Introducer due to a design defect that may cause it not to split as intended, potentially leading to serious health risks.
What Happened
Merit Medical Systems, Inc. is recalling the 16F Dual Valved Splittable Sheath Introducer due to a design defect that may prevent it from splitting as intended, which could result in hemorrhage, foreign bodies, and procedure delays.
Which Products Are Affected
The affected product is the 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), with REF: FCL-174-00/B. A total of 368,264 units are involved, distributed nationwide in the United States to states including TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV, and internationally to various countries. The specific lots affected are listed under UDI-DI/Lot codes such as I2362705, I2370091, and others up to I3257331, as per the recall number Z-1577-2026.
What You Should Do
Consumers and users should contact Merit Medical Systems, Inc. for instructions regarding this voluntary recall, as it is a firm-initiated action.
Why This Matters
This Class I recall highlights a significant safety issue with medical devices that could lead to serious health consequences, affecting a large number of units distributed across the U.S. and internationally.
Source
This information is from the FDA recall database, attributed to recall number Z-1577-2026.
Source: FDA Official Notice