Custom manifold kits recalled over inflation handles that may detach
Merit Medical Systems is recalling 2,192 Custom Manifold Kits, REF K09-13203A, because the inflation device handle may detach from the syringe during a procedure.
The agency’s classification
FDA (Food): 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: Scored 3 under the risk-of-harm criterion: the firm states the inflation device handle may detach during a procedure, and no injuries are reported.
Plain-English summary
The Merit Medical Custom Manifold Kit, REF K09-13203A, is being recalled by Merit Medical Systems, Inc.
The reason given in the enforcement record is that the inflation device handle may detach from the syringe during a procedure.
The record lists 2,192 units under UDI 00884450479964, with lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across a wide range of states. The FDA has classified the action as Class II.
A device component that detaches mid-procedure can interrupt the procedure. The enforcement record reports no injuries. Facilities should quarantine affected kits and follow Merit Medical's instructions.
The recalled product
- Product
- Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
- Manufacturer
- CATAO MARKET LLC
- Category
- Medical Device — Manifold kit
- Affected units
- 520
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 (1)
- Product identified by Best By dates (12/18/2025 through 03/18/2026)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by CATAO MARKET LLC under a single FDA (Food) 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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