Z-0068-2025Class II

BlueFIRE Inflation Device, REF: IN10140

Name: Z-0068-2025 BlueFIRE Inflation Device, REF: IN10140
Creator: Merit Medical Systems, Inc.
Published: 2024-08-19
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2024-08-19 / Open, Classified / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of BlueFIRE Inflation Device, REF: IN10140 on 2024-08-19. FDA classified it as Class II and gives the reason as "Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0068-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-19
Posted: 2024-10-11
Recalling firm: Merit Medical Systems, Inc.
Product: BlueFIRE Inflation Device, REF: IN10140
Product code: PTM Syringe, Balloon Inflation, Exempt
Reason for recall: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to [email protected] If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Quantity in commerce: 5
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
Product codes and lots: REF/UDI-DI/Lot(Expiration): IN10140/00884450363607/H2934827(4/30/2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0068-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0065-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0066-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0067-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0068-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0069-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0070-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0071-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0072-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0073-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11

Product code PTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)