Z-1820-2015Class II

Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece

Name: Z-1820-2015 Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece
Creator: Hill-Rom, Inc.
Published: 2015-03-02
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2015-03-02 / Terminated

FDA source

Hill-Rom, Inc. began a recall of Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece on 2015-03-02. FDA classified it as Class II and gives the reason as "The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1820-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-02
Posted: 2015-06-19
Terminated: 2016-05-13
Recalling firm: Hill-Rom Inc.
Product: Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Product code: HMX Cannula, Ophthalmic
Reason for recall: The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
FDA 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, [email protected] , or +44 (0)1527 587716.
Quantity in commerce: 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.
Product codes and lots: Product #s: 157400; 257400; 157500; 257500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1820-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1820-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-19

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)