CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Welch Allyn Connex Vital Signs Monitor recalled by Baxter Healthcare
Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitor. The recall was initiated on 21 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1564-2025
- FDA event ID
- 96364
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Mar 2025
- FDA classified
- 15 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 21 Mar 2025 | Recall initiated by company | |
| 15 Apr 2025 | Classified by FDA | +25 days |
| 23 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Product as listed by the FDA
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12) ) Product Code/Part # 67NXXX-B; 13) ) Product Code/Part # 68MCTP-B; 14) ) Product Code/Part # 68MCTP-B-ECG3A; 15) ) Product Code/Part # 68MCTX-B; 16) ) Product Code/Part # 68MCXX-B; 17) ) Product Code/Part # 68MXDX-B; 18) ) Product Code/Part # 68MXEP-B; 19) ) Product Code/Part # 68MXEX-B; 20) ) Product Code/Part # 68MXTP-B; 21) ) Product Code/Part # 68MXTP-B-ECG3A; 22) ) Product Code/Part # 68MXTX-B; 23) ) Product Code/Part # 68MXTX-BR; 24) ) Product Code/Part # 68NCEP-B; 25) ) Product Code/Part # 68NCTP-B; 26) ) Product Code/Part # 68NCTP-B-ECG3A; 27) ) Product Code/Part # 68NCTX-B; 28) ) Product Code/Part # 68NCXP-B; 29) ) Product Code/Part # 68NXEP-B; 30) ) Product Code/Part # 68NXEX-B; 31) ) Product Code/Part # 68NXTP-B; 32) ) Product Code/Part # 68NXTP-B-ECG3A; 33) ) Product Code/Part # 68NXTX-B; 34) ) Product Code/Part # 68NXTX-BR; 35) ) Product Code/Part # 68NXXX-B; 36) ) Product Code/Part # 67MCTP-B; 37) ) Product Code/Part # 67MCTP-B-ECG3A; 38) ) Product Code/Part # 67MCTX-B; 39) ) Product Code/Part # 67MXEX-B; 40) ) Product Code/Part # 67MXTP-B; 41) ) Product Code/Part # 68MXXX-B.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Which lots are affected?
1) Product Code/Part # 67MXTP-B-ECG3A, UDI/DI 00732094323788; 2) Product Code/Part # 67MXTX-B, UDI/DI 00732094151244; 3) Product Code/Part # 67MXXP-B, UDI/DI 00732094151237; 4) Product Code/Part # 67MXXX-B, UDI/DI 00732094151220; 5) Product Code/Part # 67NCTP-B, UDI/DI 00732094151190; 6) Product Code/Part # 67NCTP-B-ECG3A, UDI/DI 00732094323771; 7) Product Code/Part # 67NCTX-B, UDI/DI 00732094151183; 8) Product Code/Part # 67NXEX-B, UDI/DI 00732094151145; 9) Product Code/Part # 67NXTP-B, UDI/DI 00732094151138; 10) Product Code/Part # 67NXTP-B-ECG3A, UDI/DI 00732094323764; 11) Product Code/Part # 67NXTX-B, UDI/DI 00732094151121; 12) Product Code/Part # 67NXXX-B, UDI/DI 00732094151107; 13) Product Code/Part # 68MCTP-B, UDI/DI 00732094151060; 14) Product Code/Part # 68MCTP-B-ECG3A, UDI/DI 00732094345919; 15) Product Code/Part # 68MCTX-B, UDI/DI 00732094151053; 16) Product Code/Part # 68MCXX-B, UDI/DI 00732094151039; 17) Product Code/Part # 68MXDX-B, UDI/DI 00732094249187; 18) Product Code/Part # 68MXEP-B, UDI/DI 00732094150964; 19) Product Code/Part # 68MXEX-B, UDI/DI 00732094150957; 20) Product Code/Part # 68MXTP-B, UDI/DI 00732094150940; 21) Product Code/Part # 68MXTP-B-ECG3A, UDI/DI 00732094345902; 22) Product Code/Part # 68MXTX-B, UDI/DI 00732094150933; 23) Product Code/Part # 68MXTX-BR, UDI/DI 00732094322613; 24) Product Code/Part # 68NCEP-B, UDI/DI 00732094150902; 25) Product Code/Part # 68NCTP-B, UDI/DI 00732094150889; 26) Product Code/Part # 68NCTP-B-ECG3A, UDI/DI 00732094345896; 27) Product Code/Part # 68NCTX-B, UDI/DI 00732094150872; 28) Product Code/Part # 68NCXP-B, UDI/DI 00732094150865; 29) Product Code/Part # 68NXEP-B, UDI/DI 00732094150841; 30) Product Code/Part # 68NXEX-B, UDI/DI 00732094150834; 31) Product Code/Part # 68NXTP-B, UDI/DI 00732094150827; 32) Product Code/Part # 68NXTP-B-ECG3A, UDI/DI 00732094345889; 33) Product Code/Part # 68NXTX-B, UDI/DI 00732094150810; 34) Product Code/Part # 68NXTX-BR, UDI/DI 00732094322590; 35) Product Code/Part # 68NXXX-B, UDI/DI 00732094150797; 36) Product Code/Part # 67MCTP-B, UDI/DI 00732094151374; 37) Product Code/Part # 67MCTP-B-ECG3A, UDI/DI 00732094323795; 38) Product Code/Part # 67MCTX-B, UDI/DI 00732094151367; 39) Product Code/Part # 67MXEX-B, UDI/DI 00732094151268; 40) Product Code/Part # 67MXTP-B, UDI/DI 00732094151251; 41) Product Code/Part # 68MXXX-B, UDI/DI 00732094150919; Lot Number 24-314 & lower
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 96364More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |