The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0064-2025·Announced 2024-10-23

Blue Diamond Digital Inflation Devices Recalled for Sterile Barrier Defect

Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.

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: FDA Class II medical device recall with potential pathogen exposure from sterile barrier defects. No reported illnesses or injuries have been documented, qualifying as a risk-of-harm scenario without yet-reported injury per rubric criteria.

Plain-English summary

Merit Medical Systems, Inc. is recalling Blue Diamond Digital Inflation Devices (reference numbers IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, and IN7130/C). Approximately 14,120 units are affected and have been distributed nationwide throughout the United States and internationally.

The devices may contain a small hole in the sterile barrier. Use of affected devices may result in exposure to pathogens or pyrogens, which could lead to infection.

Patients and healthcare facilities who have received these devices are affected. Immediately discontinue use of affected devices and contact Merit Medical Systems, Inc. for replacement or return instructions. Healthcare facilities should identify affected inventory using the specific reference codes and lot numbers provided in the recall notice.

The recalled product

Product
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation Device
Hazard
Affected units
14,120

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 (19)

  • REF/UDI-DI/Lot(Expiration): IN7152/C/00884450381168/H2918432(4/15/2027)
  • H2925197(4/22/2027)
  • H2929406(4/29/2027)
  • H2929407(4/29/2027
  • H2934708(5/5/2027)
  • H2937991(6/3/2027)
  • H2937992(5/19/2027)
  • H2943482(5/19/2027)
  • H2972588(6/3/2027)
  • H2929409(4/29/2027)
  • H2934711(5/5/2027)
  • H2937995(5/12/2027)
  • H2943485(5/19/2027)
  • H2925196(4/22/2027)
  • H2934706(5/5/2027)
  • H2937988(6/3/2027)
  • H2943481(5/19/2027)
  • H2972587(5/26/2027)
  • H2978086(6/3/2027).

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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