The Recall Desk
HighFDA (Devices)·Z-1129-2026·Announced 2026-01-28

Angioplasty packs recalled over inflation handles that may detach

Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack 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 Allwell Angioplasty Pack, REF IS-30-B1/B 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 328,000 units under UDI 00884450653388, 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 stock and follow Merit Medical's instructions.

The recalled product

Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation device
Hazard
Affected units
328,000

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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