Reported Oct 22, 2025 · Ongoing

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3)…

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

Is this the product you have?

  • CXR Preconnect with TENACIO Pump with InhibiZone
  • UPNs(1)
  • UPN
    • 72404461 (12CM PS IZ)
    • (2) 72404462 (14CM PS IZ)
    • (3) 72404463 (16CM PS IZ)
    • (4) 72404464 (18CM PS IZ)
    • (5) 72404465 (10CM IP IZ)
    • (6) 72404466 (12CM IP IZ)
    • (7) 72404467 (14CM IP IZ)
    • (8) 72404468 (16CM IP IZ)
    • (9) 72404469 (18CM IP IZ)
Lot codes and dates
  • 1
  • UPN72404461 (12CM PS IZ)
  • UDI-DI00191506021504
  • Lot numbers
    • 1100398868
    • 1100398869
    • 1100398870
    • 1100398871
    • 1100398872
    • 1100398873
    • 1100398874
    • 1100398875
    • 1100398876
    • 1100398877
    • 1100522368
    • 1100543829
    • 1100574579
    • 1100590200
    • 1100590204
    • 1100590209
    • 1100599084
    • 1100599107
    • 1100599108
    • 1100599109
    • 1100610211
    • 1100610217
    • 1100569383
    • 1100522373
    • 1100543834
    • 1100543827
    • 1100522371
    • 1100522370
    • 1100522369
    • 1100522365
    • 1100574581
    • 1100543831
    • 1100574584
    • 1100522367
    • 1100569385
    • 1100522374
    • 1100574582
    • 1100578423
    • 1100543828
    • 1100574580
    • 1100578426
    • 1100578429
    • 1100522372
    • 1100568487
    • 1100604371
    • 1100590208
    • 1100604359
    • 1100599081
    • 1100610213
    • 1100604362
    • 2
  • UPN72404462 (14CM PS IZ)
  • UDI-DI00191506021511
  • Lot numbers
    • 1100489498
    • 1100489542
    • 1100489543
    • 1100489544
    • 1100489547
    • 1100489549
    • 1100543855
    • 1100543857
    • 1100599134
    • 1100599138
    • 1100599195
    • 1100599201
    • 1100599204
    • 1100602511
    • 1100602512
    • 1100602514
    • 1100602561
    • 1100602563
    • 1100602566
    • 1100605702
    • 1100605706
    • 1100605714
    • 1100605715
    • 1100609592
    • 1100613514
    • 1100621453
    • 1100621454
    • 1100625387
    • 1100625388
    • 1100625391
    • 1100522433
    • 1100489493
    • 1100489492
    • 1100489495
    • 1100543858
    • 1100489546
    • 1100489494
    • 1100489496
    • 1100543859
    • 1100543864
    • 1100489497
    • 1100625392
    • 1100625394
    • 1100613511
    • 1100605718
    • 1100625393
    • 1100602694
    • 1100599203
    • 1100609585
    • 1100602695
    • 1100605709
    • 1100605710
    • 1100602564
    • 1100599196
    • 1100677511
    • 1100677506
    • 1100677507
    • 1100677509
    • 1100715069
    • 3
  • UPN72404463 (16CM PS IZ)
  • UDI-DI00191506021528
  • Lot numbers

    104 of 104 codes

    • 1100480549
    • 1100480555
    • 1100480559
    • 1100480561
    • 1100480562
    • 1100480567
    • 1100492188
    • 1100511647
    • 1100511648
    • 1100511652
    • 1100511653
    • 1100511654
    • 1100511655
    • 1100511705
    • 1100511711
    • 1100546879
    • 1100546880
    • 1100546881
    • 1100551274
    • 1100551275
    • 1100551276
    • 1100551280
    • 1100560945
    • 1100560950
    • 1100565155
    • 1100565156
    • 1100565163
    • 1100565574
    • 1100565578
    • 1100565579
    • 1100565580
    • 1100565629
    • 1100565632
    • 1100565634
    • 1100565635
    • 1100602136
    • 1100602140
    • 1100602194
    • 1100602195
    • 1100602197
    • 1100602227
    • 1100602228
    • 1100602229
    • 1100605207
    • 1100605211
    • 1100605214
    • 1100614920
    • 1100615585
    • 1100615587
    • 1100619169
    • 1100619173
    • 1100619174
    • 1100657322
    • 1100657324
    • 1100657325
    • 1100511649
    • 1100565159
    • 1100511709
    • 1100560952
    • 1100480550
  • UPN72404464 (18CM PS IZ)
  • UDI-DI00191506021535
  • Lot numbers
    • 1100591058
    • 1100591064
    • 1100591059
    • 5
  • UPN72404465 (10CM IP IZ)
  • UDI-DI00191506021542
  • Lot numbers
    • 1100590252
    • 1100557278
    • 6
  • UPN72404466 (12CM IP IZ)
  • UDI-DI00191506021559
  • Lot numbers
    • 1100398535
    • 1100398536
    • 1100398537
    • 1100398538
    • 1100398539
    • 1100398540
    • 1100398541
    • 1100398542
    • 1100556794
    • 1100491464
    • 1100491466
    • 1100573736
    • 1100491465
    • 1100573773
    • 1100491472
    • 1100565103
    • 1100573739
    • 1100512182
    • 1100554190
    • 1100512180
    • 1100491470
    • 1100491471
    • 1100491467
    • 1100512183
    • 1100554188
    • 1100556786
    • 1100573737
    • 1100573738
    • 1100491463
    • 1100573774
    • 1100512181
    • 1100573732
    • 1100491469
    • 1100573730
    • 1100491468
    • 1100554187
    • 1100627360
    • 1100627357
    • 1100627355
    • 1100668336
    • 1100668329
    • 1100668337
    • 7
  • UPN72404467 (14CM IP IZ)
  • UDI-DI00191506021566
  • Lot numbers
    • 1100492102
    • 1100554145
    • 1100569162
    • 1100569187
    • 1100574563
    • 1100585072
    • 1100626261
    • 1100512197
    • 1100554148
    • 1100492110
    • 1100512198
    • 1100569181
    • 1100572069
    • 1100569180
    • 1100556843
    • 1100554150
    • 1100569165
    • 1100556842
    • 1100492104
    • 1100574559
    • 1100569179
    • 1100569161
    • 1100554146
    • 1100492103
    • 1100512202
    • 1100512196
    • 1100574566
    • 1100572068
    • 1100569159
    • 1100556839
    • 1100512201
    • 1100569184
    • 1100626262
    • 1100585076
    • 1100626260
    • 8
  • UPN72404468 (16CM IP IZ)
  • UDI-DI00191506021573
  • Lot numbers
    • 1100524763
    • 1100524766
    • 1100554179
    • 1100554180
    • 1100560191
    • 1100560905
    • 1100560907
    • 1100569608
    • 1100569612
    • 1100569649
    • 1100569656
    • 1100573275
    • 1100574054
    • 1100574055
    • 1100574058
    • 1100574059
    • 1100574062
    • 1100624980
    • 1100624983
    • 1100624987
    • 1100624988
    • 1100626293
    • 1100626296
    • 1100554173
    • 1100560903
    • 1100524760
    • 1100573278
    • 1100569609
    • 1100490867
    • 1100569610
    • 1100524761
    • 1100560908
    • 1100554175
    • 1100560197
    • 1100574056
    • 1100569605
    • 1100554177
    • 1100574057
    • 1100574060
    • 1100490863
    • 1100560900
    • 1100569648
    • 1100573273
    • 1100573269
    • 1100569604
    • 1100560906
    • 1100569657
    • 1100524758
    • 1100626288
    • 1100626295
    • 1100626292
    • 9
  • UPN72404469 (18CM IP IZ)
  • UDI-DI00191506021580
  • Lot numbers
    • 1100624977
    • 1100624974
    • 1100624975
    • 1100624978
    • 1100624969
    • 1100624976
    • 1100624970
    • 1100624973
Amount recalled
172 units

This recall covers 34 products

The agency filed one notice per product. You are reading one of them; the other 33 are below.

21 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.