Drugs & medicalClass II

Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Read the official notice →
Date
2026-06-24
Country
United States
Brand
Steris
Product
HarmonyAIR A-Series Surgical Lighting System
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Australia, Canada,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Steris recalls

  1. 2026-10-14
  2. US
    Drugs & medicalClass II

    Steris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…

    A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect…

    FDA · DeviceSteris CorporationWorldwide - US Nationwide and the countries of Australia, Canada, New Zealand.Official notice →
  3. US
    Drugs & medicalClass II

    Steris Corporation recalls VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

    Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological…

    FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution.Official notice →
  4. 2026-06-24
  5. US
    Drugs & medicalClass II

    Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System

    The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

    FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution.Official notice →
  6. 2026-02-18
  7. US
    Drugs & medicalClass II

    Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

    FDA · DeviceSteris CorporationUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Official notice →
  8. 2025-12-17
  9. US
    Drugs & medicalClass II

    Steris Corporation recalls AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use…

    Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

    FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution in the states of Arizona, Colorado,…Official notice →
  10. 2025-08-06
  11. US
    Drugs & medicalClass II

    Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

    The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring…

    FDA · DeviceSteris CorporationWorldwide - US Nationwide and Puerto Rico and the country of Canada.Official notice →
All 18 Steris recalls →

Other drugs & medical recalls in the United States

  1. 2026-06-24
  2. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

    Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent…

    FDA · DeviceSmith & Nephew, Inc.International distribution to the countries of BE, DE, IT.Official notice →
  3. US
    Drugs & medicalClass II

    Medtronic Navigation, Inc.-Boxborough recalls Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

    Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

    FDA · DeviceMedtronic Navigation, Inc.-BoxboroughWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  4. US
    Drugs & medicalClass II

    Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System

    The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

    FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING…

    Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

    FDA · DeviceMedline Industries, LPUS Nationwide distribution. OUS distribution pending.Official notice →
  6. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for…

    Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US and ROW.Official notice →
  7. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL, LLC recalls Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT:…

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if…

    FDA · DeviceARROW INTERNATIONAL, LLCUS Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN,…Official notice →
See all drugs & medical recalls →