Model L43K Intraoperative Probe-For the diagnostic ultrasound… — Class II medical device recall Z-2308-2021
Ongoing recall by Hitachi Healthcare Americas Corporation, reported 2021-08-25, distributed nationwide. The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised
| Recall number | Z-2308-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Healthcare Americas Corporation, Twinsburg, OH, United States |
| Recall initiated | 2021-06-30 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 120 units |
| Serial numbers | 203R8980, 203R8981, 203R8986, 203R8987, 203R8988, 203R9022, 203R9023, 203R9031, 203R9032, 203R9033, 203R9034, 203R9035, 203R9036, 203R9037, 203R9038, 203R9041, 203R9042, 203R9047, 203R9048, 204J8480, 204J8481, 204J8482, 204J8483, 204J8484, 204Q3434 and 140 more |
| Model numbers | L43K |
Product
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.