Food, drugs, devices › Steris Corporation
Device recall: Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Ster
Steris Corporation (Mentor, OH) initiated this device recall on 4 Apr 2014; FDA lists 1 product record under event 68128, 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 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Oct 2014. Initiation: voluntary: firm initiated. Steris Corporation has 58 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
Steris Corporation, Mentor, OH.
Reason for recall
"Potential for the welded seam in affected monitor spring arms to crack and/or break."
Distribution
"Distribution to US (states: MA, NY, OH, PA & TX) and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1850-2014 | Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262. | 68 units | Class II | Terminated | 2 Jul 2014 |
Context
Other enforcement events for Steris Corporation
All 58 events for Steris Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for the welded seam in affected monitor spring arms to crack and/or break."
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: "Distribution to US (states: MA, NY, OH, PA & TX) and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Oct 2014. "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.