Prelude Sheath Introducer 7.5F devices recalled due to labeling error
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a dimensional labeling error (7F devices labeled as 7.5F). The mislabeling presents a risk of harm through incorrect device sizing in medical procedures; however, no illnesses or injuries have been reported in the source material.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Prelude Sheath Introducer 7.5F (model PSI-7F-11-038 Version F) due to a labeling error. The affected devices are labeled as 7.5F but are actually sized as 7F.
The recall affects approximately 1,892 units distributed in the United States and Mexico. Affected devices are identified by lot codes H2874685 (expiration 09-Mar-2027), H2878374 (expiration 26-FEB-2027), and H2904232 (expiration 11-MAY-2027).
The dimensional mislabeling means that devices intended to be 7.5F are instead sized as 7F. Healthcare facilities and patients who may have received these devices should verify the actual device size against the lot numbers and model information provided and contact Merit Medical Systems for instructions regarding replacement or return of the affected devices.
The recalled product
- Product
- Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 1,892
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- H2878374 (26-FEB-2027)
- H2904232 (11-MAY-2027)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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