Use cautionMedical device recall · FDA · Published March 21, 2023
Merit Medical COBRA-OS Sheath Kit Recall: Incorrect Needle Size Hazard
Merit Medical recalls COBRA-OS custom sheath kits with incorrect needle size that could cause injury during medical procedures. Affected kits have specific lot numbers and were sold with a sterile, single-use label.
“Merit Medical COBRA-OS Sheath Kit Recall: Incorrect Needle Size Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58729-merit-medical-cobra-os-sheath-kit-recall-incorrect-needle-size. Based on FDA recall #Z-1578-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1578-2023%22&limit=1).
The FDA announced on March 21, 2023, that Merit Medical Systems, Inc. is voluntarily recalling COBRA-OS custom Sheath Introducer Kits due to an incorrect needle size. The recall affects 1,186 units distributed in Minnesota.
How to tell if you have it
Brand: Merit Medical
Product: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Lot #: H2122096S1
UDI-DI: (00)884450525197
The hazard
The custom sheath introducer contains an incorrect needle size. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since February 24, 2006. Other recent recalls of similar products include Embosphere 500-700 Micrometer Syringe Recall (August 10, 2026), Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), Philips Bridge Prep Kit Recall (April 2, 2026), Oscor Abiomed Introducer Kit Recall (June 10, 2026), and Arrow Percutaneous Sheath Introducer Recall (March 11, 2026).
How to tell if you have this one
Check for the lot number H2122096S1 on the kit packaging. The product is labeled as 'Sterile EO, Single Use, RX Only, 5 Units' with the model REF: E01P2.
Brand
Merit Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the lot number H2122096S1 and model REF: E01P2 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in Minnesota.
Listed by the agency
Not listed
FDA distribution: “US Distribution to state of: Minnesota” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Minnesota.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1578-2023 (March 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1578-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.