FDA Medical Device Recalls (openFDA)
Hill-Rom, Inc.: Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
- Recall number
- Z-1820-2015
- Recalling firm
- Hill-Rom, Inc.
- Product
- Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
- Status
- Terminated
- Initiated
- 2015-03-02
- Posted
- 2015-06-19
- Terminated
- 2016-05-13
- Reason
- The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
- Root cause
- Use error
- Action
- Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.
- Quantity
- 66691 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
- Lot, serial or model codes
- Product #s: 157400; 257400; 157500; 257500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 1824206
- Firm city
- Batesville
- Firm state
- IN
- 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