Device recall: Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

FDA enforcement event 70675 · Class II · initiated 2 Mar 2015 · status Terminated · terminated 13 May 2016

DeviceVoluntary: Firm initiated1 product recordBatesville, IN

Hill-Rom, Inc. (Batesville, IN) initiated this device recall on 2 Mar 2015; FDA lists 1 product record under event 70675, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 13 May 2016. Initiation: voluntary: firm initiated. Hill-Rom, Inc. has 28 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Hill-Rom, Inc., Batesville, IN.

Reason for recall

"The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece."

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 records

Recall number	Product	Quantity	Class	Status	Report date
Z-1820-2015	Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.	66691 units	Class II	Terminated	1 Jul 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

28events on this register for the firm

Other enforcement events for Hill-Rom, Inc.

Initiated	Product (first record)	Type	Class	Records
14 Jan 2022	(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX compon	Device	Class II	1
23 Dec 2021	Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010	Device	Class II	2
14 Oct 2021	These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, P	Device	Class II	1
11 Aug 2021	OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center	Device	Class II	5
28 May 2021	Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) o	Device	Class II	1
18 Dec 2020	Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive	Device	Class I	1
30 Jun 2020	Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complicatio	Device	Class II	2
30 Apr 2020	Centrella Smart+ Bed, Catalog Number P7900	Device	Class II	1
14 Feb 2020	NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is comp	Device	Class II	1
12 Jan 2018	Progressa Bed - AC-powered adjustable hospital bed	Device	Class II	1

All 28 events for Hill-Rom, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.