Use cautionMedical device recall · FDA · Published January 4, 2022
BALT USA Optima Coil System: Label Mix-up Risk
BALT USA recalls Optima Coil System due to incorrect labeling potentially causing wrong coil size selection during procedures, risking vessel damage or aneurysm rupture. Affected units have specific model and lot numbers.
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
Take action
Contact the company
📍Recalling firmBALT USA, LLC29 Parker Ste 100 · Irvine, CA 92618-1667
✎ GovInfoNow plain-language explainer
BALT USA is recalling its Optima Coil System because of a labeling mix-up that could lead to selecting the wrong coil size during medical procedures. This might cause vessel damage, treatment failure, or aneurysm rupture if the incorrect coil is used. Read more at govinfonow.com/recall/61319-balt-usa-optima-coil-system-label-mix-up-risk.
“BALT USA Optima Coil System: Label Mix-up Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61319-balt-usa-optima-coil-system-label-mix-up-risk. Based on FDA recall #Z-0660-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2022%22&limit=1).
BALT USA, LLC voluntarily recalled The Optima Coil System due to a labeling mix-up that could lead to selecting the incorrect coil size, according to the FDA. The agency announced the Class II recall on January 4, 2022.
How to tell if you have it
Brand: BALT USA
Product: The Optima Coil System
Model/REF: OPTI0204CSF10, Lot Number: F210500134, UDI Code: 00818053026010
Model/REF: OPTI0407CSF10, Lot Number: F210500135, UDI Code: 00818053026096
The hazard
The recall addresses pouches incorrectly labeled due to inadequate manufacturing line clearance. This error creates the possibility of inadvertently selecting the incorrect coil size for a procedure, potentially causing vessel damage, an inability to treat with the device, and potential rupture of the aneurysm.
Context
GovInfoNow's records show BALT USA, LLC has issued five other recalls since July 26, 2022. Recent brand recalls include a May 8, 2025 Optima Coil System recall for radiopaque marker visibility issues and a January 3, 2024 recall regarding corrosion risk in the delivery pusher. Other recent recalls of similar products include BD InLay Optima Ureteral Stent Kit label mismatch risks (November 6, 2025) and a Bard Ureteral Stent Kit recall for label size mismatch risk (November 6, 2025).
How to tell if you have this one
Check for model numbers OPTI0204CSF10 or OPTI0407CSF10 with lot numbers F210500134 or F210500135. The product is sold by BALT USA and includes a UDI code starting with 008180530260.
Brand
BALT USA
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Verify the model number and lot number on the product to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of FL and MD. The countries of Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and United Arab Emirates.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Maryland.
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-0660-2022 (January 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0660-2022 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.