Witt Biomedical Corporation Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
Brand
Witt Biomedical Corporation
Lot Codes / Batch Numbers
Serial numbers 970424D to 200501499.
Products Sold
Serial numbers 970424D to 200501499.
Witt Biomedical Corporation is recalling Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. due to Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
Recommended Action
Per FDA guidance
Consignees will be notified of recall by phone, the firm will use a phone script.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026