FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- Recall number
- Z-1578-2023
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- Status
- Open, Classified
- Initiated
- 2023-03-21
- Posted
- 2023-05-10
- Terminated
- not on file
- Reason
- Custom sheath Introducer contains incorrect needle size
- Root cause
- Unknown/Undetermined by firm
- Action
- On March 21, 2023 MeritMedical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. In addition to informing them about the recall, MeritMedical 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. Please fill out, scan and email the completed Customer Response Form to Customer Service at OEMorder@merit.com within seven (7) calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. If you have any questions concerning this communication, please don t hesitate to contact your Merit OEM Sales Representative or Merit OEM Customer Service at (800)-637-4839| Hours: 8 am to 5 pm MST | Mon-Fri.
- Quantity
- 1186 units
- Distribution
- US Distribution to state of: Minnesota
- Lot, serial or model codes
- Lot # H2122096S1; UDI-DI: (00)884450525197
- 510(k) numbers
- ["K070159"]
- PMA numbers
- not on file
- Product code
- DYB
- 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