FDA recall, , High risk
Cook Centimeter Sizing Catheters
Marker bands may be at an increased risk of cracking/breakage.
Summary by Recall Canary from the FDA notice
What happened
Cook Incorporated is recalling certain Aurous Centimeter Sizing Catheters, Beacon Tip Centimeter Sizing Catheters, and Centimeter Sizing Catheters because the marker bands may be at an increased risk of cracking/breakage.
Potential adverse events include increased procedural time, harms associated with device fragmentation/separation, and vessel injury; in a worst-case scenario, fragmentation and separation may cause life-threatening harm or death.
The recall began April 2, 2026, and was added to the FDA's Enforcement Report on May 1, 2026, with distribution nationwide and to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- UDI-DI
- 00827002473089
- 16858459
- 16869145
- 16857138
- 16763324
- 16750208
- 16752733
- 16821053
- 16713191
Product details
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- UDI-DI
- 00827002312135
- 16805456
- 00827002312142
- 16886459
- 16874181
- 16855513
- 16867505
- 16815763
- 16796665
- 16802282
- 16766437
- 16734169
- 16695772
- 00827002312166
- 16886460
- 16891299
- 16912494
- 16831676
- 16836358
- 16836359
- 16836360
- 16864534
- 16864652
- 16881655
- 16882508
- 16912493
- 16872559
- 16878260
- 16824312
- 16831675
- 16874182
- 16855514
- 16868889
- 16859732
- 16858079
- 16878261
- 16806270
- 16804619
- 16805454
- 16804399
- 16815762
- 16803920
- 16803921
- 16802096
- 16802097
- 16814369
- 16814370
- 16806333
- 16804620
- 16831528
- 16822289
- 16822290
- 16782945
- 16782946
- 16795733
- 16796300
- 16779437
- 16795734
- 16800424
- 16802632
- 16824313
- 16764526
- 16763024
- 16800730
- 16802633
- 16802133
- 16800731
- 16821105
- 16824314
- 16711110
- 16717839
- 16730326
- 16720153
- 16736740
- 16739291
- 16693653
- 16690051
- 16673569
- 16680240
- 16704378
- 00827002312203
- 16881657
- 16872241
- 16827163
- 16852999
- 16805455
- 16804400
- 16802132
- 16779438
- 16730325
- 16739292
- 16700199
- 16690050
- 16661312
- 16674400
- 00827002312210
- 16839296
- 16879977
- 16814371
- 16821104
- Lot code
- G31214
- G31216
- G31220
- G31221
Product details
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
- UDI-DI
- 00827002119161
- 16905390
- 16888263
- 16905391
- 16909577
- 16918137
- 16924645
- 16924646
- 16928311
- 16928312
- 16928313
- 16947353
- 16899656
- 16899655
- 16894976
- 16879299
- 16890985
- 16903201
- 16885859
- 16890986
- 16890982
- 16888268
- 16904428
- 16899658
- 16903202
- 16903203
- 16903204
- 16905389
- 16888267
- 16890983
- 16888269
- 16890981
- 16879296
- 16864346
- 16879301
- 16888261
- 16864344
- 16864351
- 16846774
- 16869144
- 16879300
- 16864350
- 16869143
- 16879297
- 16861735
- 16864347
- 16882666
- 16899657
- 16890984
- 16899659
- 16888266
- 16861729
- 16857145
- 16858460
- 16857141
- 16861730
- 16861724
- 16858463
- 16852206
- 16855698
- 16858458
- 16858461
- 16858462
- 16861726
- 16861727
- 16861728
- 16852209
- 16855686
- 16855696
- 16857146
- 16859718
- 16861720
- 16861723
- 16861725
- 16857137
- 16857142
- 16857139
- 16857140
- 16877835
- 16864345
- 16882665
- 16864353
- 16864348
- 16865462
- 16879302
- 16843256
- 16833320
- 16843258
- 16845235
- 16845236
- 16839886
- 16845242
- 16845244
- 16845223
- 16845226
- 16846777
- 16845230
- 16845227
- 16833315
- 16845218
- 16845246
- 16845233
- 16846778
- 16845229
- 16845240
- 16846779
- 16845241
- 16855694
- 16851384
- 16855695
- 16852208
- 16855693
- 16855697
- 16852207
- 16851381
- 16861733
- 16852711
- 16855688
- 16849691
- 16846771
- 16846776
- 16845231
- 16851379
- 16851378
- 16851374
- 16846775
- 16851376
- 16855690
- 16849688
- 16846770
- 16846773
- 16861731
- 16861732
- 16864352
- 16864354
- 16857144
- 16855691
- 16855692
- 16846772
- 16851380
- 16861734
- 16864349
- 16851382
- 16857143
- 16833228
- 16833298
- 16833292
- 16833321
- 16845239
- 16836838
- 16839887
- 16823055
- 16807168
- 16816808
- 16823045
- 16833290
- 16833299
- 16836839
- 16833316
- 16833314
- 16833310
- 16823062
- 16825484
- 16833229
- 16833230
- 16833231
- 16833232
- 16833289
- 16833307
- 16833308
- 16833309
- 16833311
- 16833312
- 16833313
- 16833296
- 16845237
- 16802095
- 16833301
- 16833302
- 16843254
- 16843255
- 16843257
- 16845234
- 16833297
- 16833293
- 16833304
- 16833300
- 16802091
- 16833291
- 16833303
- 16800397
- 16800399
- 16802092
- 16823046
- 16823047
- 16823048
- 16823049
- 16823050
- 16823051
- 16823052
- 16823053
- 16823054
- 16823059
- 16823060
- 16823061
- 16825481
- 16830073
- 16823064
- 16825482
- 16823056
- 16825483
- 16802093
- 16833306
- 16802094
- 16800398
- 16833305
- 16823063
- 16833226
- 16833227
- 16841922
- 16845228
- 16845238
- 16849686
- 16849687
- 16833319
- 16833318
- 16849689
- 16849690
- 16849692
- 16849693
- 16851375
- 16851377
- 16833317
- 16845224
- 16845222
- 16845243
- 16845245
- 16845225
- 16845219
- 16845232
- 16855689
- 16851383
- 16851385
- 16855687
- 16823058
- 16823057
- 16830072
- 16833295
- 16833294
- 16785145
- 16800393
- 16785154
- 16800392
- 16785156
- 16763331
- 16763325
- 16779065
- 16763326
- 16785147
- 16781909
- 16785146
- 16785148
- 16785149
- 16785150
- 16785155
- 16800395
- 16800396
- 16795825
- 16778880
- 16778879
- 16778886
- 16778882
- 16768075
- 16778874
- 16778875
- 16778876
- 16778877
- 16778878
- 16779066
- 16779067
- 16779073
- 16780712
- 16780713
- 16755901
- 16763332
- 16760667
- 16768078
- 16763329
- 16763330
- 16713193
- 16726029
- 16727639
- 16726031
- 16720477
- 16721538
- 16731107
- 16731108
- 16731109
- 16731110
- 16734930
- 16734931
- 16726034
- 16721055
- 16752735
- 16718409
- 16734933
- 16716743
- 16752732
- 16748454
- 16748455
- 16734939
- 16720476
- 16779063
- 16778884
- 16779064
- 16778885
- 16779068
- 16716747
- 16716742
- 16716745
- 16781899
- 16783621
- 16785142
- 16778873
- 16742510
- 16742505
- 16781901
- 16781900
- 16781906
- 16781902
- 16763334
- 16763327
- 16742512
- 16742511
- 16758715
- 16755900
- 16760665
- 16758716
- 16758713
- 16778881
- 16758712
- 16758717
- 16755905
- 16758718
- 16763328
- 16800390
- 16789989
- 16789992
- 16789991
- 16789993
- 16795822
- 16795823
- 16797411
- 16768077
- 16768076
- 16779062
- 16768074
- 16778883
- 16779069
- 16779072
- 16780717
- 16779071
- 16780714
- 16781908
- 16781907
- 16783615
- 16780719
- 16780718
- 16781903
- 16797412
- 16800394
- 16781904
- 16785153
- 16789990
- 16783619
- 16780715
- 16780716
- 16779070
- 16785143
- 16785151
- 16800391
- 16823044
- 16795826
- 16813575
- 16807167
- 16781905
- 16785152
- 16785144
- 16783620
- 16783622
- 16797413
- 16795824
- 16807169
- 16807166
- 16699267
- 16700950
- 16707903
- 16711577
- 16711578
- 16694273
- 16694279
- 16696442
- 16703558
- 16703557
- 16713192
- 16700951
- 16694277
- 16694275
- 16696441
- 16726030
- 16726033
- 16716744
- 16721060
- 16718408
- 16758710
- 16734936
- 16721057
- 16734937
- 16713194
- 16721056
- 16734934
- 16734938
- 16752736
- 16758708
- 16758711
- 16716749
- 16721058
- 16734935
- 16734932
- 16758709
- 16755904
- 16716750
- 16721053
- 16716748
- 16726032
- 16700948
- 16700946
- 16716741
- 16758714
- 16716746
- 16755903
- 16760666
- 16755902
- 16752734
- 16721059
- 16783616
- 16783623
- 16783618
- 16783617
- 16720473
- 16711579
- 16711580
- 16711581
- 16720472
- 16720474
- 16720475
- 16721061
- 16721062
- 16721054
- 16707899
- 16700949
- 16700947
- 16699182
- 16694280
- 16707901
- 16700945
- 16699177
- 16699179
- Lot code
- 16905390X
- NS16888264
- 16905391X
- 16928311X
- 16869143X
- NS16861721
- 16864347X
- 16858462X
- 16865462X
- 16845223X
- NS16845220
- NS16845220X
- 16861731X
- NS16861722
- 16861734X
- 16857143X
- 16836839X
- 16823062X
- 16802091X
- NS16845221
- NS16760664
- 16800395X
- 16800396X
- 16778880X
- NS16731105
- NS16731106
- NS16760663
- 16742511X
- 16789989X
- 16789992X
- 16823044X
- 16700948X
- 16758714X
Recall details
- Company began the recall
- Sold in
US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
- Company
- Cook IncorporatedBloomington, Indiana
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98682
- Recall numbers
- Z-1934-2026 to Z-1936-2026
All recalls from Cook Incorporated
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
