FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
- Recall number
- Z-1549-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
- Status
- Open, Classified
- Initiated
- 2025-03-05
- Posted
- 2025-04-09
- Terminated
- not on file
- Reason
- Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Root cause
- Under Investigation by firm
- Action
- Medline issued a "Medline ReNewal IMMEDIATE ACTION REQUIRED" notice dated 3/5/2025, to its consignees on 03/05/2025 via USPS first class mail. The notice explained the issue, potential risk, and requested the following actions: REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Upon receipt of your submitted response form, FedEx return label(s) will be provided. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. For questions, please contact 866-359-1704 or recalls@medline.com.
- Quantity
- 224 units
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- UDI/DI 10080196415106, Lot Numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.
- 510(k) numbers
- ["K012669"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28