Source: US Department of Health and Human Services – 3
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
Affected Serial Numbers for Z-800 (UDI-DI: 00814377102006)
800242
801925
802867
900875
901058
901089
901101
901126
901143
901567
904021
904073
800378
801950
803020
900914
901061
901090
901102
901129
901145
901795
904023
904083
801082
802113
803268
900961
901066
901091
901103
901130
901230
904004
904026
904087
801353
802131
803526
900964
901070
901092
901110
901131
901240
904006
904027
904093
801420
802160
803768
901001
901076
901093
901112
901132
901241
904007
904028
904094
801503
802645
900029
901014
901077
901094
901113
901133
901244
904009
904029
905077
801601
802753
900035
901024
901081
901095
901115
901134
901245
904011
904030
905162
801640
802764
900051
901041
901083
901096
901116
901136
901246
904012
904031
906681
801852
802771
900115
901054
901085
901097
901117
901138
901249
904013
904038
906692
801855
802774
900133
901055
901086
901098
901118
901140
901250
904014
904040
906693
801881
802780
900147
901056
901087
901099
901119
901141
901252
904018
904042
906716
801884
802798
900569
901057
901088
901100
901123
901142
901255
904020
904053
906720
906721
Affected Serial Numbers for Z-800F (UDI-DI: 00814371020013)
600091
600133
600203
600259
600320
600361
600404
600446
600482
600526
600565
600601
600094
600138
600204
600261
600321
600362
600406
600447
600483
600528
600566
600603
600095
600139
600206
600262
600322
600363
600407
600449
600485
600529
600568
600604
600099
600141
600207
600263
600323
600364
600408
600450
600487
600531
600569
600605
600100
600142
600209
600265
600324
600369
600410
600451
600488
600532
600570
600608
600102
600143
600211
600266
600325
600370
600411
600452
600489
600533
600571
600609
600104
600146
600215
600267
600326
600376
600412
600453
600490
600535
600572
600610
600105
600148
600217
600268
600328
600377
600414
600454
600495
600536
600573
600611
600106
600150
600220
600270
600330
600378
600415
600456
600496
600539
600574
600612
600108
600151
600223
600271
600331
600379
600416
600457
600498
600540
600575
600613
600109
600152
600224
600289
600335
600383
600417
600458
600499
600541
600576
600614
600110
600153
600227
600292
600336
600384
600418
600460
600504
600542
600577
600615
600111
600154
600228
600294
600338
600385
600419
600461
600505
600543
600578
600617
600112
600155
600229
600295
600339
600386
600422
600462
600506
600545
600579
600618
600113
600156
600230
600297
600341
600387
600423
600464
600509
600546
600580
600921
600114
600157
600231
600298
600342
600388
600424
600465
600510
600549
600583
601325
600115
600158
600235
600299
600343
600389
600425
600466
600511
600551
600584
601433
600116
600159
600238
600300
600344
600391
600427
600467
600513
600553
600585
601514
600118
600160
600239
600301
600347
600392
600430
600470
600514
600554
600586
601603
600120
600161
600240
600302
600348
600393
600431
600471
600516
600555
600587
601651
600121
600162
600249
600303
600349
600394
600432
600473
600517
600556
600589
602578
600122
600164
600250
600304
600350
600396
600436
600474
600518
600557
600591
602743
600126
600165
600251
600305
600351
600398
600437
600475
600519
600558
600592
602807
600127
600168
600252
600306
600352
600399
600438
600476
600520
600559
600594
603858
600129
600174
600253
600308
600353
600400
600440
600477
600521
600560
600595
604637
600130
600176
600254
600309
600356
600401
600442
600478
600522
600562
600596
605411
600131
600188
600255
600310
600357
600402
600443
600480
600523
600563
600599
605870
600132
600192
600257
600319
600359
600403
600445
600481
600525
600564
600600
605918
605964
606886
607077
607891
608058
608061
608612
613123
614776
Affected Serial Numbers for Z-800W (UDI-DI: 00814371020020)
700063
700163
700203
700402
700488
700093
700169
700210
700428
700495
700104
700172
700214
700431
700503
700111
700188
700225
700440
700510
700120
700189
700230
700449
700513
700135
700190
700285
700460
700541
700145
700192
700375
700471
700481
700150
700195
700391
700472
700397
700159
700199
700393
700478
700201
700162
Affected Serial Numbers for Z-800WF (UDI-DI: 00814371020037)
500004
500005
500006
500810
500812
500813
501748
503680
503681
503682
What to Do
On May 7, 2025 Zyno Medical sent all affected customers an email recommending the following actions:
Discontinue use of affected devices and follow instructions for the return of the device.
Check inventory for affected products, verify serial numbers, and confirm product location.
Report any transferred product and pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location.
A representative from Zyno Medical’s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.
Reason for Recall
Zyno Medical stated that certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.
The worst case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, air in line that infuses a venous air embolism of up to 1mL, undetected flow reversal of drugs or parenteral fluids, and lowering of the Keep Vein Open (KVO) rate from 5 mL/hr to 1 mL/hr, which can lead to very low KVO flow rates and possibly cause a blood clot to form at the distal end of the catheter, ultimately leading to peripheral IV catheter (PIV) failure.
At this time, Zyno Medical has not reported any serious injuries or deaths.
Device Use
The Zyno Medical Z-800 Infusion System is intended to provide intravenous infusion ofparenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Zyno Medical at feedback@intuvie.com or 508-650-2008.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Content current as of:
06/16/2025
Regulated Product(s)