The Recall Desk
HighFDA (Devices)·Z-0070-2025·Announced 2024-10-23

Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk

Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.

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: This is an FDA Class II recall involving a sterile barrier defect in medical devices. Although no illnesses or injuries have been reported in the source text, the hazard involves exposure to pathogens and pyrogens with risk of serious infection. Per the severity rubric, a risk-of-harm medical device where injury has not yet been reported scores as High (3).

Plain-English summary

Merit Medical Systems, Inc. is recalling Custom Inflation Kits with various reference numbers (7,099 units total) distributed worldwide. The devices are used in medical procedures that require inflation.

The recall was initiated because affected devices may have a small hole in the sterile barrier. This defect could expose users to pathogens and pyrogens, which may lead to serious infection.

The affected kits have been distributed nationwide across the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. Specific lot numbers and expiration dates are identified in the FDA recall notice.

Patients who have received these devices should consult their healthcare provider immediately. Healthcare providers should stop using affected inventory and contact Merit Medical Systems for device replacement or instructions.

The recalled product

Product
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • pathogen-exposure
  • infection-risk

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 (20)

  • REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027)
  • H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027)
  • H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027)
  • H2925236(4/22/2027)
  • H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026)
  • H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027)
  • H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027)
  • H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027)
  • H2934834(5/5/2027)
  • H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027)
  • H2934744(5/5/2027)
  • H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027)
  • H2934746(5/5/2027)
  • H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/2027)
  • H2929514(4/29/2027)
  • H2938623(5/12/2027). K05-00798/00884450046951/H2925242(4/22/2027)
  • H2943609(5/19/2027). K05-00890D/00884450453629/H2918449(4/15/2027)
  • H2929515(4/29/2027). K05-00890D/00884450453629/H2934749(5/5/2027)
  • H2943610(5/19/2027). K05-00944D/00884450151631/H2918450(4/15/2027)
  • H2929516(4/29/2027). K05-00956D/00884450142448/H2918511(4/15/2027)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category