Z-1820-2015 Class II Terminated
FDA device recall Z-1820-2015 was initiated by Hill-Rom, Inc. on Mar 2, 2015 and is designated Class II. Reason for recall: The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. The recall status is terminated (terminated May 13, 2016). Affected quantity: 66691 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 1, 2015
- Initiation Date
- Mar 2, 2015
- Termination Date
- May 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66691 units
Product Description
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Reason for Recall
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Distribution Pattern
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.
Code Information
Product #s: 157400; 257400; 157500; 257500
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1820-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026