The Recall Desk
HighFDA (Devices)·Z-1123-2026·Announced 2026-01-28

basixCOMPAK inflation devices recalled over handles that may detach

Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

What this means for you

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 Inflation Device basixCOMPAK, 30 atm/bar, 20 mL is being recalled by Merit Medical Systems, Inc., covering reference numbers ENDO-AN2030/B, IN4130/CNK, IN4130/H, IN4130/JPH, IN4130/K, IN4130/KRK, IN4130/L, IN4130/T, IN4230/JPH, IN4230/K, IN4330/CNK, IN4330/K, IN4352/K, IN4430/K, IN4530/CNK, IN4530/K and IN4530/T, with further reference numbers listed in the enforcement record.

The reason given in the enforcement record is that the inflation device handle may detach from the syringe during a procedure.

The record lists 4,163,123 units, with UDI and 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 stock and follow Merit Medical's instructions.

The recalled product

Product
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation device
Hazard
Affected units
4,163,123

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 7 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.

See all 7 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · component detachment

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