Hitachi Healthcare L43K Intraoperative Probe Recall: Screw Cover May Fall Off After
Hitachi Healthcare recalls L43K Intraoperative Probes with serial numbers listed; screw cover may fall off after cleaning/sterilization, requiring pre-use checks before procedures.
Use caution until it’s fixed
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
Contact the company
What happened, in plain English
Hitachi Healthcare is recalling specific L43K Intraoperative Probes due to a screw cover that can fall off after cleaning or sterilization. This could lead to the probe becoming unsafe during surgery if not checked properly before use. Read more at govinfonow.com/recall/62263-hitachi-healthcare-l43k-intraoperative-probe-recall-screw-cover-may-fall.
Source Summary by GovInfoNow · govinfonow.com/recall/62263-hitachi-healthcare-l43k-intraoperative-probe-recall-screw-cover-may-fall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2308-2021
Cite this page
“Hitachi Healthcare L43K Intraoperative Probe Recall: Screw Cover May Fall Off After.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62263-hitachi-healthcare-l43k-intraoperative-probe-recall-screw-cover-may-fall. Based on FDA recall #Z-2308-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2308-2021%22&limit=1).
Why it’s dangerous
The screw cover at the probe tip may detach after cleaning or sterilization. If it falls off during surgery, it could interfere with the procedure or cause injury to the patient.
Who’s affected
Surgical teams and hospitals using the recalled L43K Intraoperative Probes for robotic or laparoscopic procedures. Surgeons and medical staff handling these probes during operations are most at risk.
How to tell if you have this one
Check for serial numbers listed in the recall: 20504835 through 206E0059 and others. The probe is used for intraoperative ultrasound during robotic or laparoscopic surgeries.
- Brand
Hitachi Healthcare- Category
Medical device
What to do — step by step
Check Probe Before Use
Inspect the screw cover at the probe tip before and after cleaning, sterilization, and each surgical procedure to ensure it remains securely attached.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2308-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2308-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.