Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 26, 2022
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product pouch label does not match up with carton label
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Balt USA, LLC recalled Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used … - a moderate-severity action.
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used … was recalled by Balt USA, LLC in October 26, 2022. Reason: Product pouch label does not match up with carton label. Check the official notice for the remedy. Verify recall #Z-0103-2023 with the FDA Devices before acting.
The recall
Balt USA, LLC issued this moderate-severity FDA Devices recall-Product pouch label does not match up with carton label.
- Moderate
- severity level
- Class II
- classification
- October 26, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0103-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0103-2023) was formally reported on October 26, 2022, with the manufacturer initiating the action on September 7, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Balt USA, LLC is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 41 impacted devices.
The documented reason for this recall is: Product pouch label does not match up with carton label Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
41 impacted devices
Related Recalls
6
3 from same agency
Product description
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Reason for recall
Product pouch label does not match up with carton label
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0103-2023 |
| Date reported | October 26, 2022 |
| Date initiated | September 7, 2022 |
| Recalling firm | Balt USA, LLC |
| Firm location | Irvine, CA |
| Affected scope | 41 impacted devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0103-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.. Recalled by Balt USA, LLC. Units affected: 41 impacted devices.
Why was this product recalled? ▼
Product pouch label does not match up with carton label
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0103-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0103-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 26, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.