Datascope Corp Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
Brand
Datascope Corp
Lot Codes / Batch Numbers
Serial Numbers: CM16830-E2, CM17664-C3, CM02100-D0, CM21267-B3, CM01262-B0, CM17728-F3, CM14167-L1, CM15062-B2, TM05314-D3, TM03604-A3, TM03630-A3, TM03642-A3, TM04059-B3, CM11122-F1, CM02057-D0, CM10756-F1, CM01376-B0, CM06107-K0, CM08770-C1, CM04116-H0, CM03838-G0, CM15058-B2, CM10359-F1, TM04721-C3, CM03958-G0, CM12388-I1, CM11462-G1, TM04175-B3, CM04386-H0, CM04445-H0, CM12571-I1, CM12778-I1, CM11479-G1, CM11776-H1, CM03556-F0, CM17319-E2, TM03982-A3, CM10360-F1, CM13887-K1, TM06058-F3, CM07526-B1, CM17683-F3, CM17715-F3, CM14479-A2, CM04265-H0, CM04703-I0, CM16756-E2, TM04809-C3, TM01569-H2, TM03602-A3, TM03603-A3, TM04091-B3, CM14979-B2, CM14986-B2, CM09445-D1, CM09479-D1, CM09935-E1, CM10117-E1, CM16268-D2, CM16451-D2, CM16540-D2, CM20116-F2, CM20117-F2, CM20130-F2, CM20160-F2, CM20196-F2, CM20203-F2, CM20216-F2, CM20218-F2, CM20219-F2, CM20220-F2, CM20221-F2, CM20529-F2, CM20531-F2, CM20533-F2, CM20537-F2, CM20538-F2, TM03635-A3, TM03639-A3, TM03647-A3, TM05447-E3, TM05457-E3, TM06085-G3, TM06109-G3, TM06119-G3, TM06129-G3, TM06152-G3, TM06154-G3, TM06170-G3, TM06270-H3, TM06280-H3, TM06282-H3, TM06317-H3, TM06337-H3, TM06363-H3, TM06386-H3, CM12173-H1, CM03670-F0, CM10041-E1, CM10721-F1, CM17422-E2, CM14065-L1, CM01200-L9, CM10711-F1, CM13006-J1, CM09686-D1, CM16023-C2, CM07488-B1, CM06584-L0, CM14498-A2, CM11945-H1, CM09924-E1, CM10163-E1, TM0555733-E3, CM12712-I1, TM04453-B3, TM03615-A3, CM04707-I0, CM08494-C1, TM04593-B3, TM06051-F3, CM04641-I0, CM12252-H1, CM16585-D2, CM04089-H0, CM09094-D1, TM06056-F3, TM06057-F3, TM06060-F3, YM06061-F3, CM06521-L0, CM04176-H0, TM01305-H2, TM03623-A3, TM03637-A3, TM03631-A3, CM04739-I0, CM13335-J1, CM05366-J0, CM05379-J0, CM07674-B1, CM12608-I1, CM04078-H0, TM01934-I2, TM03605-A3, TM03614-A3, CM05787-K0, CM12519-I1, CM16699-E2, CM09685-D1, CM10622-F1, CM13227-J1, CM17680-E3, TM02741-K2, CM05243-J0, CM05992-K0, CM13985-L1, TM05504-E3, TM03338-L2, CM11689-H1, TM04360-B3, CM03934-G0, CM10757-F1, CM10768-F1, CM10771-F1, TM05692-E3, TM05710-E3, CM1099-L9, CM17684-F3, CM16059-C2, CM03133-E0, CM01660-C0, CM15956-C2, CM14371-LI, CM06098-K0, CM07733-B1, CM09173-D1, CM06805-L0, CM10013-E1, CM04005-G0, CM07697-B1, TM05835-F3, TM05840-F3, TM05854-F3, TM05872-F3, TM05905-F3, TM05912-F3, TM05921-F3, TM05947-F3, TM05956-F3, CM01797-C0, TM02210-J2, CM05139-J0, CM11127-F1, TM01614-H2, CM09611-D1, TM05714-E3, TM03476-A3, TM03627-A3, TM03684-A3, TM05824-E3, CM07628-B1.
Products Sold
Serial Numbers: CM16830-E2; CM17664-C3; CM02100-D0; CM21267-B3; CM01262-B0; CM17728-F3; CM14167-L1; CM15062-B2; TM05314-D3; TM03604-A3; TM03630-A3; TM03642-A3; TM04059-B3; CM11122-F1; CM02057-D0; CM10756-F1; CM01376-B0; CM06107-K0; CM08770-C1; CM04116-H0; CM03838-G0; CM15058-B2; CM10359-F1; TM04721-C3; CM03958-G0; CM12388-I1; CM11462-G1; TM04175-B3; CM04386-H0; CM04445-H0; CM12571-I1; CM12778-I1; CM11479-G1; CM11776-H1; CM03556-F0; CM17319-E2; TM03982-A3; CM10360-F1; CM13887-K1; TM06058-F3; CM07526-B1; CM17683-F3; CM17715-F3; CM14479-A2; CM04265-H0; CM04703-I0; CM16756-E2; TM04809-C3; TM01569-H2; TM03602-A3; TM03603-A3; TM04091-B3; CM14979-B2; CM14986-B2; CM09445-D1; CM09479-D1; CM09935-E1; CM10117-E1; CM16268-D2; CM16451-D2; CM16540-D2; CM20116-F2; CM20117-F2; CM20130-F2; CM20160-F2; CM20196-F2; CM20203-F2; CM20216-F2; CM20218-F2; CM20219-F2; CM20220-F2; CM20221-F2; CM20529-F2; CM20531-F2; CM20533-F2; CM20537-F2; CM20538-F2; TM03635-A3; TM03639-A3; TM03647-A3; TM05447-E3; TM05457-E3; TM06085-G3; TM06109-G3; TM06119-G3; TM06129-G3; TM06152-G3; TM06154-G3; TM06170-G3; TM06270-H3; TM06280-H3; TM06282-H3; TM06317-H3; TM06337-H3; TM06363-H3; TM06386-H3; CM12173-H1; CM03670-F0; CM10041-E1; CM10721-F1; CM17422-E2; CM14065-L1; CM01200-L9; CM10711-F1; CM13006-J1; CM09686-D1; CM16023-C2; CM07488-B1; CM06584-L0; CM14498-A2; CM11945-H1; CM09924-E1; CM10163-E1; TM0555733-E3; CM12712-I1; TM04453-B3; TM03615-A3; CM04707-I0; CM08494-C1; TM04593-B3; TM06051-F3; CM04641-I0; CM12252-H1; CM16585-D2; CM04089-H0; CM09094-D1; TM06056-F3; TM06057-F3; TM06060-F3; YM06061-F3; CM06521-L0; CM04176-H0; TM01305-H2; TM03623-A3; TM03637-A3; TM03631-A3; CM04739-I0; CM13335-J1; CM05366-J0; CM05379-J0; CM07674-B1; CM12608-I1; CM04078-H0; TM01934-I2; TM03605-A3; TM03614-A3; CM05787-K0; CM12519-I1; CM16699-E2; CM09685-D1; CM10622-F1; CM13227-J1; CM17680-E3; TM02741-K2; CM05243-J0; CM05992-K0; CM13985-L1; TM05504-E3; TM03338-L2; CM11689-H1; TM04360-B3; CM03934-G0; CM10757-F1; CM10768-F1; CM10771-F1; TM05692-E3; TM05710-E3; CM1099-L9; CM17684-F3; CM16059-C2; CM03133-E0; CM01660-C0; CM15956-C2; CM14371-LI; CM06098-K0; CM07733-B1; CM09173-D1; CM06805-L0; CM10013-E1; CM04005-G0; CM07697-B1; TM05835-F3; TM05840-F3; TM05854-F3; TM05872-F3; TM05905-F3; TM05912-F3; TM05921-F3; TM05947-F3; TM05956-F3; CM01797-C0; TM02210-J2; CM05139-J0; CM11127-F1; TM01614-H2; CM09611-D1; TM05714-E3; TM03476-A3; TM03627-A3; TM03684-A3; TM05824-E3; CM07628-B1.
Datascope Corp is recalling Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system. due to Potential inaccurate printed information in the upper and lower margins of a print strip.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential inaccurate printed information in the upper and lower margins of a print strip.
Recommended Action
Per FDA guidance
Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.
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