CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report
Steriseal-Cannula Ophthalmic recalled by Hill-Rom
Hill-Rom is recalling Steriseal-Cannula Ophthalmic, distributed nationwide in the US. The recall was initiated on 2 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1820-2015
- FDA event ID
- 70675
- Recalling firm
- Hill-Rom, Batesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2015
- FDA classified
- 19 Jun 2015
- Reported
- 1 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 2 Mar 2015 | Recall initiated by company | |
| 19 Jun 2015 | Classified by FDA | +109 days |
| 1 Jul 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Which lots are affected?
Product #s: 157400; 257400; 157500; 257500
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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