FDA event 96364 · Recall Observatory

device · product 1 of 7

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.

Z-1562-2025

Recall number: Z-1562-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 8233 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 2 of 7

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.

Z-1563-2025

Recall number: Z-1563-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 70627 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 3 of 7

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.

Z-1564-2025

Recall number: Z-1564-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 40166 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 4 of 7

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.

Z-1565-2025

Recall number: Z-1565-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 34187 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 5 of 7

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.

Z-1566-2025

Recall number: Z-1566-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 135 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 6 of 7

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.

Z-1567-2025

Recall number: Z-1567-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 385920 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 7 of 7

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.

Z-1568-2025

Recall number: Z-1568-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 76407 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Code information

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;

Distribution pattern

Worldwide distribution.

Event 96364

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

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Reason for recall

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Reason for recall

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Distribution pattern

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.

Reason for recall

Code information

Distribution pattern

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.

Reason for recall

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Reason for recall

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Distribution pattern

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.

Reason for recall

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Distribution pattern