MEDLINE ReNewal ENT Coblator II PROcise XP Wand — Class II medical device recall Z-1548-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-16, distributed nationwide. Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line
| Recall number | Z-1548-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-03-05 |
| Classified | 2025-04-09 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 315 units |
| UPC / GTIN / UDI-DI | 10888277395374 |
| Lot numbers | 506894, 509420, 512983, 513469, 514448, 514549, 515557, 515860, 515903, 516550, 517359, 517626, 519259, 519413, 519966, 520277, 521360, 522144, 522145, 525472, 527111, 527115, 527121, 528456, 528457, 528582, 529483, 529485, 529487, 529489, 529930, 530432, 530433, 530434, 531020, 531024, 531676 |
| Model numbers | EICA88720R |
Product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Reason for recall
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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-1548-2025. 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.