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…
Read the official notice →- Date
- 2026-10-14
- Country
- United States
- Brand
- Steris
- Product
- HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…
- Classification
- Class II
- Units
- Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2026-10-14
USSteris 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…
- 2026-06-24
- US
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.
- US
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.
FDA · DeviceSteris CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2026-02-18
- US
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 → - 2025-12-17
- US
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 → - 2025-08-06
- US
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 →
Other drugs & medical recalls in the United States
- 2026-10-14
- US
Intellijoint Surgical, Inc. recalls Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint…
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may…
FDA · DeviceIntellijoint Surgical, Inc.Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the…Official notice → - US
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.Official notice → - US
Mindray DS USA, Inc. recalls ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- US
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice → - US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCWorldwide - US Nationwide distribution in the states and territory of AK, AR,…Official notice → - US
AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Official notice →