Agency classClass IIOur severity:High FDA (Devices)·Z-2178-2025·Announced 2025-08-06

HarmonyAIR E-Series monitor yokes may detach from the spring arm

Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a suspended monitor assembly above a surgical field may come away from its arm, with no injury reported in the source.

Plain-English summary

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled. The action covers 59 units, UDI 00724995171155, identified by the serial numbers in the recall notice.

The stated reason is that the DFPM yoke assembly may detach from the spring arm. According to the notice, should the yoke assembly detach from the spring arm, it would not be expected to fully detach but rather to hang from the wiring within the yoke assembly. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States, Puerto Rico and Canada. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the UDI and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Manufacturer: Steris Corporation
Category: Medical Device — Surgical lighting accessory
Hazard: yoke-detachment
suspended-load
surgical-lighting
class-ii
Affected units: 59

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI: 00724995171155: Serial numbers: 0416920048
0417820084
0417820088
0417820096
0417820110
0417820092
0417820100
0418420047
0419620004
0419520013
0428620109
0428620112
0430020191
0431720044
0435120043
0435120047
0435120051
0401321042
0413221047
0413221199

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Steris Corporation

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Same hazard · yoke detachment