Route 92 Medical — Class I medical device recall Z-1612-2024
Ongoing recall by ROUTE 92 MEDICAL INC, reported 2024-05-01, distributed in AL, AZ, CA, DE, FL, GA, IA, IL…. Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
| Recall number | Z-1612-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROUTE 92 MEDICAL INC, San Mateo, CA, United States |
| Recall initiated | 2024-03-08 |
| Classified | 2024-04-24 |
| Reported by FDA | 2024-05-01 |
| Distributed | AL, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SD, TN, TX, UT, VA, WV |
| Countries outside the US | NZ |
| Quantity | 117 units |
| UPC / GTIN / UDI-DI | 00853799007442 |
| Lot numbers | 23061601, 23081802, 23100601, 23102601, 24010306, 24011801, 24020801 |
| Model numbers | 1004 |
Product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reason for recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1612-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.