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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Steris Surgical Monitor Accessories Recalled for Risk of Detachment

Agency Publication Date: July 25, 2025
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Summary

Steris Corporation is recalling approximately 226 monitor mount accessories used with HarmonyAIR A-Series and E-Series Surgical Lighting Systems. The mount (yoke assembly) that holds the monitors can detach from the support arm, which may cause the monitor to fall and hang only by its internal electrical wiring. This recall affects accessories sold worldwide, including throughout the United States, Puerto Rico, and Canada. No injuries or accidents have been reported at this time.

Risk

If the monitor mount detaches from its support arm during a medical procedure, it could strike patients or surgical staff, or cause significant delays during critical surgeries. While the monitor is expected to hang by its internal wiring rather than falling completely, the movement poses a risk of impact or interruption.

What You Should Do

  1. This recall involves Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series (UDI 00724995203245) and HarmonyAIR E-Series (UDI 00724995171155) Surgical Lighting Systems.
  2. Check the serial number on the accessory mounting to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Steris Corporation or your authorized medical equipment distributor to arrange for a return, replacement, or correction of the yoke assembly.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Serial Numbers (167):
0400224028
0401625167
0401625171
0401625180
0401625185
0401625190
0402022165
0402022169
0402422003
0402622007
0402925148
0403122053
0403122057
0403125009
0403223079
0403223083
0403223087
0403223091
0403321066
0403321070
0403423063
0403423067
0403423071
0403423075
0403423079
0403423083
0403423087
0404022003
0404622011
0404622014
0404622017
0404622020
0404622023
0404822104
0405025032
0405924100
0405924103
0406624134
0406624138
0406624142
0406722052
0406722056
0406722060
0406722064
0406823005
0407625022
0408025008
0408222120
0408222124
0408222128
UDI:
00724995203245

Recall #: Z-2177-2025. Quantity: 167 units.

Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Serial Numbers (59):
0416920048
0417820084
0417820088
0417820096
0417820110
0417820092
0417820100
0418420047
0419620004
0419520013
0428620109
0428620112
0430020191
0431720044
0435120043
0435120047
0435120051
0401321042
0413221047
0413221199
0413721008
0413721012
0417221023
0417221027
0417221031
0420021018
0420021022
0420021026
0420721021
0429720003
0420921073
0426321186
0426321190
0427121121
0427121125
0427321012
0427321002
0427321005
0413921017
0434121095
0434121098
0434121101
0434121104
0434121107
0434121110
0434121113
0400722081
0406022021
0406022025
0406022034
UDI:
00724995171155

Recall #: Z-2178-2025. Quantity: 59 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97068
Status: Active
Manufacturer: Steris Corporation
Sold By: Direct sales; Authorized medical equipment distributors
Manufactured In: United States
Units Affected: 2 products (167 units; 59 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.