FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
- Recall number
- Z-1916-2023
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-04-22
- Posted
- 2023-06-14
- Terminated
- not on file
- Reason
- There is a potential that valve assemblies will not open. preventing fluid from draining.
- Root cause
- Process control
- Action
- Beginning on April 22, 2023, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx and UPS. On May 31, 2023, Merit Medical expanded the scope and notified additional consignees. Merit Medical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 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 CRF. Additional distribution details may be required by health authorities. 4. For Aspira Valve Replacement Kits, please immediately return all affected product in your possession to Merit, per the instructions in the attached CRF. 5. For Aspira Insertion Trays, follow the attached instructions for placing the recall labels. At the point of use, the valve assembly in the Insertion Tray is to be discarded and replaced by one of the replacement Aspira Valve Repair Kits. 6. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within seven (7) days. All affected product shipped to you must be accounted for on the CRF. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Quantity
- 2559 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
- Lot, serial or model codes
- Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960
- 510(k) numbers
- ["K110396","K212675"]
- PMA numbers
- not on file
- Product code
- PNG
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28