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.
Read the official notice →- Date
- 2026-06-24
- Country
- United States
- Brand
- Medtronic Navigation, Inc.-Boxborough
- Product
- Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medtronic Navigation, Inc.-Boxborough recalls
- 2025-07-16
US
Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
FDA · DeviceMedtronic Navigation, Inc.-BoxboroughUS Nationwide distribution in the states of IN, MN, MS.Official notice →
Other drugs & medical recalls in the United States
- 2026-06-24
US
AMD Medicom Inc. recalls Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C;…
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that…
US
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
FDA · DeviceAbiomed, Inc.US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to…Official notice →US
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 →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 →US
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 →