BALT Optima Coil System Recall: Pouch Label Mismatch Risk
BALT USA recalls Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to pouch label not matching carton labels. This mismatch may cause confusion during medical procedures.
Lower-risk recall
Product pouch label does not match up with carton label
Contact the company
What happened, in plain English
BALT USA is recalling two models of Optima Coil System used in endovascular procedures because the product pouch label does not match the carton label. This mismatch could lead to confusion during medical procedures, potentially affecting patient safety. Read more at govinfonow.com/recall/60085-balt-optima-coil-system-recall-pouch-label-mismatch-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60085-balt-optima-coil-system-recall-pouch-label-mismatch-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0103-2023
Cite this page
“BALT Optima Coil System Recall: Pouch Label Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60085-balt-optima-coil-system-recall-pouch-label-mismatch-risk. Based on FDA recall #Z-0103-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0103-2023%22&limit=1).
Why it’s dangerous
The product pouch label does not match the carton label, which could lead to confusion during medical procedures. This mismatch might cause the wrong model to be used, potentially affecting patient safety.
Who’s affected
Medical professionals using the Optima Coil System for endovascular procedures are most at risk. Patients receiving these procedures may be affected if the label mismatch causes errors.
How to tell if you have this one
Check for model numbers OPTI0208CSS10 or OPTI0308CSS10 on the product pouch and carton. The lot numbers are F220601068 and F220601089 respectively.
- Brand
BALT- Category
Medical device
What to do — step by step
Check Labels
Verify that the product pouch label matches the carton label for model numbers OPTI0208CSS10 or OPTI0308CSS10.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, North Carolina, Pennsylvania.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall is for label mismatch, which may cause confusion but does not indicate a risk of serious injury in normal use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-0103-2023 (September 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0103-2023 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.