Lower risk Medical device recall · FDA · Published March 21, 2025
Welch Allyn Connex Vital Signs Monitor Recall: Undeclared Rubber Band in Blood Pressure
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitors with certain blood pressure cuff models due to undeclared natural rubber bands in packaging that could cause injury.
Lower-risk recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Contact the company
Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
What happened, in plain English
Baxter Healthcare Corporation is recalling Welch Allyn Connex Vital Signs Monitors with specific blood pressure cuff models because packaging contains undeclared natural rubber bands. This could cause injury if the rubber band is accidentally used during blood pressure measurements. Read more at govinfonow.com/recall/52566-welch-allyn-connex-vital-signs-monitor-recall-undeclared-rubber-band.
Source Summary by GovInfoNow · govinfonow.com/recall/52566-welch-allyn-connex-vital-signs-monitor-recall-undeclared-rubber-band · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1564-2025
Cite this page
“Welch Allyn Connex Vital Signs Monitor Recall: Undeclared Rubber Band in Blood Pressure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52566-welch-allyn-connex-vital-signs-monitor-recall-undeclared-rubber-band. Based on FDA recall #Z-1564-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2025%22&limit=1).
Why it’s dangerous
The recall involves undeclared natural rubber bands inside the packaging of certain blood pressure cuff configurations. If the rubber band is accidentally used during blood pressure measurements, it could cause injury. The hazard is not a direct risk to the user but a potential for injury if the rubber band is mishandled.
Who’s affected
Healthcare professionals and individuals who use Welch Allyn Connex Vital Signs Monitors with the listed blood pressure cuff models are affected. Those most at risk are users who might accidentally use the rubber band during blood pressure measurements.
How to tell if you have this one
Check your Welch Allyn Connex Vital Signs Monitor for blood pressure cuffs with Product Code/Part Numbers listed in the recall notice. The affected models include 67MXTP-B-ECG3A and other specific codes listed in the recall.
- Brand
Welch Allyn- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1562-2025 | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B; 18) 84MTVXX-2; 19) 84MXVEC-4; 20) 84MXVEC-B; 21) 84MXVEP-4; 22) 84MXVEP-B; 23) 84NTVE2-6; 24) 84NTVE2-B; 25) 84NTVE2-US; 26) 84NTVEC-B; 27) 84NTVX2-6; 28) 84NTVX2-B; 29) 84NTVX2-US; 30) 84NTVXC-4; 31) 84NTVXC-B; 32) 84NTVXP-B; 33) 84NXVEC-4; 34) 84NXVEC-6; 35) 84NXVEC-B; 36) 84XTVXC-2; 37) 84XTVXC-B; 38) 85MTVE3-2; 39) 85MTVE3-4; 40) 85MTVE3-B; 41) 85MTVE3-US; 42) 85MTVEC-4; 43) 85MTVEC-B; 44) 85MTVEP-2; 45) 85MTVEP-B; 46) 85MTVX3-4; 47) 85MTVX3-B; 48) 85MTVX3-US; 49) 85MTVXC-6; 50) 85MTVXC-B; 51) 85MTVXX-6; 52) 85MXVEC-2; 53) 85MXVEC-4; 54) 85MXVEC-B; 55) 85MXVEP-4; 56) 85NTVE3-4; 57) 85NTVE3-6; 58) 85NTVE3-B; 59) 85NTVE3-US; 60) 85NTVEC-B; 61) 85NTVEP-2; 62) 85NTVEP-6; 63) 85NTVEP-B; 64) 85NTVX3-6; 65) 85NTVX3-B; 66) 85NTVX3-US; 67) 85NTVXC-B; 68) 85NTVXP-2; 69) 85NTVXP-B; 70) 85NXVEC-4; 71) 85NXVEC-B; 72) 85NXVEP-6.; 1) Product Code/Part # 84MTVE2-4, UDI/DI 00732094350548; 2) Product Code/Part # 84MTVE2-6, UDI/DI 00732094350463; 3) Product Code/Part # 84MTVE2-B, UDI/DI 00732094349856; 4) Product Code/Part # 84MTVE2-US, UDI/DI 00732094350388; 5) Product Code/Part # 84MTVEC-6, UDI/DI 00732094058741; 6) Product Code/Part # 84MTVEC-B, UDI/DI 00732094058734; 7) Product Code/Part # 84MTVEP-B, UDI/DI 00732094119442; 8) Product Code/Part # 84MTVEX-4, UDI/DI 00732094198638; 9) Product Code/Part # 84MTVX2-4, UDI/DI 00732094350531; 10) Product Code/Part # 84MTVX2-6, UDI/DI 00732094350456; 11) Product Code/Part # 84MTVX2-B, UDI/DI 00732094349849; 12) Product Code/Part # 84MTVX2-US, UDI/DI 00732094350371; 13) Product Code/Part # 84MTVXC-4, UDI/DI 00732094058550; 14) Product Code/Part # 84MTVXC-B, UDI/DI 00732094058512; 15) Product Code/Part # 84MTVXP-2, UDI/DI 00732094198607; 16) Product Code/Part # 84MTVXP-4, UDI/DI 00732094058390; 17) Product Code/Part # 84MTVXP-B, UDI/DI 00732094058352; 18) Product Code/Part # 84MTVXX-2, UDI/DI 00732094198584; 19) Product Code/Part # 84MXVEC-4, UDI/DI 00732094198553; 20) Product Code/Part # 84MXVEC-B, UDI/DI 00732094058277; 21) Product Code/Part # 84MXVEP-4, UDI/DI 00732094058260; 22) Product Code/Part # 84MXVEP-B, UDI/DI 00732094058222; 23) Product Code/Part # 84NTVE2-6, UDI/DI 00732094350449; 24) Product Code/Part # 84NTVE2-B, UDI/DI 00732094349832; 25) Product Code/Part # 84NTVE2-US, UDI/DI 00732094350364; 26) Product Code/Part # 84NTVEC-B, UDI/DI 00732094058048; 27) Product Code/Part # 84NTVX2-6, UDI/DI 00732094350432; 28) Product Code/Part # 84NTVX2-B, UDI/DI 00732094349825; 29) Product Code/Part # 84NTVX2-US, UDI/DI 00732094350357; 30) Product Code/Part # 84NTVXC-4, UDI/DI 00732094198362; 31) Product Code/Part # 84NTVXC-B, UDI/DI 00732094057775; 32) Product Code/Part # 84NTVXP-B, UDI/DI 00732094057713; 33) Product Code/Part # 84NXVEC-4, UDI/DI 00732094057652; 34) Product Code/Part # 84NXVEC-6, UDI/DI 00732094057638; 35) Product Code/Part # 84NXVEC-B, UDI/DI 00732094057485; 36) Product Code/Part # 84XTVXC-2, UDI/DI 00732094198096; 37) Product Code/Part # 84XTVXC-B, UDI/DI 00732094057065; 38) Product Code/Part # 85MTVE3-2, UDI/DI 00732094350586; 39) Product Code/Part # 85MTVE3-4, UDI/DI 00732094350500; 40) Product Code/Part # 85MTVE3-B, UDI/DI 00732094349818; 41) Product Code/Part # 85MTVE3-US, UDI/DI 00732094350340; 42) Product Code/Part # 85MTVEC-4, UDI/DI 00732094197808; 43) Product Code/Part # 85MTVEC-B, UDI/DI 00732094118964; 44) Product Code/Part # 85MTVEP-2, UDI/DI 00732094056211; 45) Product Code/Part # 85MTVEP-B, UDI/DI 00732094056174; 46) Product Code/Part # 85MTVX3-4, UDI/DI 00732094350494; 47) Product Code/Part # 85MTVX3-B, UDI/DI 00732094349801; 48) Product Code/Part # 85MTVX3-US, UDI/DI 00732094350333; 49) Product Code/Part # 85MTVXC-6, UDI/DI 00732094196221; 50) Product Code/Part # 85MTVXC-B, UDI/DI 00732094056075; 51) Product Code/Part # 85MTVXX-6, UDI/DI 00732094196245; 52) Product Code/Part # 85MXVEC-2, UDI/DI 00732094197693; 53) Product Code/Part # 85MXVEC-4, UDI/DI 00732094197686; 54) Product Code/Part # 85MXVEC-B, UDI/DI 00732094118940; 55) Product Code/Part # 85MXVEP-4, UDI/DI 00732094055887; 56) Product Code/Part # 85NTVE3-4, UDI/DI 00732094350487; 57) Product Code/Part # 85NTVE3-6, UDI/DI 00732094350401; 58) Product Code/Part # 85NTVE3-B, UDI/DI 00732094349795; 59) Product Code/Part # 85NTVE3-US, UDI/DI 00732094350326; 60) Product Code/Part # 85NTVEC-B, UDI/DI 00732094055740; 61) Product Code/Part # 85NTVEP-2, UDI/DI 00732094197532; 62) Product Code/Part # 85NTVEP-6, UDI/DI 00732094196320; 63) Product Code/Part # 85NTVEP-B, UDI/DI 00732094055597; 64) Product Code/Part # 85NTVX3-6, UDI/DI 00732094350395; 65) Product Code/Part # 85NTVX3-B, UDI/DI 00732094349788; 66) Product Code/Part # 85NTVX3-US, UDI/DI 00732094350319; 67) Product Code/Part # 85NTVXC-B, UDI/DI 00732094055467; 68) Product Code/Part # 85NTVXP-2, UDI/DI 00732094055443; 69) Product Code/Part # 85NTVXP-B, UDI/DI 00732094055412; 70) Product Code/Part # 85NXVEC-4, UDI/DI 00732094055252; 71) Product Code/Part # 85NXVEC-B, UDI/DI 00732094055207; 72) Product Code/Part # 85NXVEP-6, UDI/DI 00732094196375; Lot Number 24-314 & lower | 8233 units |
| Z-1563-2025 | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75MT-BR; 19) 75MX-B; 20) 75RE-B; 21) 75RT-B; 22) 75WE-B; 23) 75WT-B.; 1) Product Code/Part # 73WT-B, UDI/DI 00732094210033; 2) Product Code/Part # 74CE-B, UDI/DI 00732094209921; 3) Product Code/Part # 74CT-B, UDI/DI 00732094209860; 4) Product Code/Part # 74CX-B, UDI/DI 00732094209792; 5) Product Code/Part # 74ME-B, UDI/DI 00732094209716; 6) Product Code/Part # 74MT-B, UDI/DI 00732094209679; 7) Product Code/Part # 74MX-B, UDI/DI 00732094209624; 8) Product Code/Part # 74RE-B, UDI/DI 00732094335781; 9) Product Code/Part # 74RT-B, UDI/DI 00732094335712; 10) Product Code/Part # 75CE-B, UDI/DI 00732094209570; 11) Product Code/Part # 75CT-B, UDI/DI 00732094209518; 12) Product Code/Part # 75CT-BR, UDI/DI 00732094322491; 13) Product Code/Part # 75CX-B, UDI/DI 00732094209464; 14) Product Code/Part # 75-HCA-CTB, UDI/DI 00732094240597; 15) Product Code/Part # 75-HCA-MTB, UDI/DI 00732094240603; 16) Product Code/Part # 75ME-B, UDI/DI 00732094209419; 17) Product Code/Part # 75MT-B, UDI/DI 00732094209372; 18) Product Code/Part # 75MT-BR, UDI/DI 00732094322477; 19) Product Code/Part # 75MX-B, UDI/DI 00732094209334; 20) Product Code/Part # 75RE-B, UDI/DI 00732094335606; 21) Product Code/Part # 75RT-B, UDI/DI 00732094335538; 22) Product Code/Part # 75WE-B, UDI/DI 00732094210712; 23) Product Code/Part # 75WT-B, UDI/DI 00732094209167; Lot Number 24-314 & lower | 70627 units |
| Z-1564-2025 | 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.; 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 | 40166 units |
| Z-1565-2025 | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.; 1) Product Code/Part # 44WT-2, UDI/DI 00732094309461; 2) Product Code/Part # 44WT-3, UDI/DI 00732094309454; 3) Product Code/Part # 44WT-4, UDI/DI 00732094309447; 4) Product Code/Part # 44WT-6, UDI/DI 00732094309423; 5) Product Code/Part # 44WT-B, UDI/DI 00732094309409; 6) Product Code/Part # 44XT-2, UDI/DI 00732094309386; 7) Product Code/Part # 44XT-4, UDI/DI 00732094309362; 8) Product Code/Part # 44XT-6, UDI/DI 00732094309348; 9) Product Code/Part # 44XT-B, UDI/DI 00732094309324; Lot Number 24-314 & lower | 34187 units |
| Z-1566-2025 | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.; 1) Product Code/Part # 77791-2MP2X, UDI/DI 00732094066890; 2) Product Code/Part # 77791-2MP2XL, UDI/DI 00732094201833; 3) Product Code/Part # 77791-2MPX, UDI/DI 00732094066876; 4) Product Code/Part # 77791-2MPX-HS, UDI/DI 00732094231045; 5) Product Code/Part # 77791-2MPXL, UDI/DI 00732094201826; 6) Product Code/Part # 77796-2MPX, UDI/DI 00732094066289; 7) Product Code/Part # 77796-2MPXL, UDI/DI 00732094184013; Lot Number 24-314 & lower | 135 units |
| Z-1567-2025 | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.; 1) Product Code/Part # 5098-02, UDI/DI 00732094110128; Product Code/Part # 5098-23, UDI/DI 00732094109900; Product Code/Part # 5098-27, UDI/DI 00732094109856; Product Code/Part # 5098-28, UDI/DI 00732094109801; Product Code/Part # 5098-29, UDI/DI 00732094109764; Product Code/Part # 5098-30, UDI/DI 00732094109726; Product Code/Part # 5098-33, UDI/DI 00732094109658; Product Code/Part # 5098-42, UDI/DI 00732094109603; Product Code/Part # DS44-09, UDI/DI 00732094085884; Product Code/Part # DS44-11, UDI/DI 00732094085631; Product Code/Part # DS44-11C, UDI/DI 00732094085617; Product Code/Part # DS44-MC, UDI/DI 00732094084924; Product Code/Part # DS45-11, UDI/DI 00732094084610; Product Code/Part # DS45-11C, UDI/DI 00732094084498; Product Code/Part # DS45-12, UDI/DI 00732094084429; Product Code/Part # DS45-MC, UDI/DI 00732094083965; Product Code/Part # DS58-11, UDI/DI 00732094083385; Product Code/Part # DS58-MC, UDI/DI 00732094083347; Product Code/Part # DS58-PD, UDI/DI 00732094083309; Product Code/Part # DS58-ST, UDI/DI 00732094083170; 2) Product Code/Part Number 407637, UDI/DI 00732094046755; 3) Product Code/Part Number 7670-10,UDI/DI 00732094071511; Lot Number 24-314 & lower | 385920 units |
| Z-1568-2025 | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.; 1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Product Code/Part # 47-23-189, UDI/DI 00732094002362; Product Code/Part # 5082-01, UDI/DI 00732094113723; Product Code/Part # 5082-01H, UDI/DI 00732094113693; Product Code/Part # 5082-02, UDI/DI 00732094113679; Product Code/Part # 5082-03, UDI/DI 00732094113648; Product Code/Part # 5082-07, UDI/DI 00732094113631; Product Code/Part # 5082-08, UDI/DI 00732094113600; Product Code/Part # 5082-11, UDI/DI 00732094113327; Product Code/Part # 5082-16, UDI/DI 00732094113105; Product Code/Part # 5082-21, UDI/DI 00732094112344; Product Code/Part # 5082-22, UDI/DI 00732094112290; Product Code/Part # 5082-22H, UDI/DI 00732094112276; Product Code/Part # 5082-23, UDI/DI 00732094112245; Product Code/Part # 5082-23H, UDI/DI 00732094112221; Product Code/Part # 5082-24, UDI/DI 00732094112207; Product Code/Part # 5082-25, UDI/DI 00732094111996; Product Code/Part # 5082-26, UDI/DI 00732094111897; Product Code/Part # 5082-42, UDI/DI 00732094111873; Product Code/Part # 5082-43, UDI/DI 00732094111842; Product Code/Part # 5082-44, UDI/DI 00732094111811; Product Code/Part # 5082-45, UDI/DI 00732094111798; Product Code/Part # 5082-77, UDI/DI 00732094111644; Product Code/Part # 4500-02, UDI/DI 00732094004199; Product Code/Part # 4500-03, UDI/DI 00732094004182; Product Code/Part # 45-15-389, UDI/DI 00732094004472; Product Code/Part # 45-22-189, UDI/DI 00732094004397; Product Code/Part # 45-23-189, UDI/DI 00732094004380; Product Code/Part # 5082-78, UDI/DI 00732094111613; Product Code/Part # 5200-01, UDI/DI 00732094108583; Product Code/Part # 5200-02, UDI/DI 00732094108569; 2) Product Code/Part Number 410519, UDI/DI 00732094208610; Product Code/Part Number 5090-41, UDI/DI 00732094110494; Lot Number 24-314 & lower Product Code/Part Number 5098-20, UDI/DI 00732094109955; | 76407 units |
What to do — step by step
Check Cuff Model
Identify your blood pressure cuff model by checking the Product Code/Part Number on the cuff packaging or label.
Verify Affected Model
Compare your model number with the list of affected Product Code/Part Numbers provided in the recall notice.
How this recall unfolded
Recall timeline
FDA published this recall 33 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.
Questions people ask
What should I do if my cuff is affected?
Identify your model and compare it to the affected list. If it matches, you should stop using it and contact Welch Allyn for further instructions.
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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-1564-2025 (March 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1564-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.