FDA recall, , Moderate risk
Cook Medical Guide Wires, Catheter Sets and Trays
Cook Medical devices were labeled with expiration dates that exceed their true shelf life.
Summary by Recall Canary from the FDA notice
What happened
Cook Incorporated, of Bloomington, Indiana, began a recall on March 5, 2026, of multiple medical devices, including the Medical Arterial Pressure Monitoring Tray, Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set, Medical Wayne Pneumothorax Set, Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Medical Cook Strange Bile Duct Stone Exploration Set, Medical Spectrum Central Venous Tray, Medical Approach CTO-18 Micro Wire Guide, and Medical Spectrum Central Venous Catheter Set, because the products were labeled with expiration dates that exceed the true shelf life.
The FDA added the recall to its Enforcement Report and classified it on April 6, 2026, with worldwide distribution.
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.
Cook Medical Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
- UDI-DI
- 00827002507883
- 15660224
- 00827002507920
- 15220204
- Lot code
- 15898546X
Cook Medical Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
- UDI-DI
- 00827002584129
- 00827002584198
- Lot code
- 15894185X
- 15747314X
- 15264260X
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
- UDI-DI
- 00827002321939
- 00827002476653
- 16191668
- 16195472
- 16195467
- 16191666
- 16191677
- 16191661
- 16200360
- 16185929
- 16237917
- 16191674
- 16191671
- 16193388
- 16193387
- 16191667
- 16195473
- 16191662
- 16191689
- 16195468
- 16271019
- Lot code
- NS16189671
Cook Medical Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
- UDI-DI
- 00827002565371
- 15834145
- 15834147
- Lot code
- 15719344X
- 15714808X
Product details
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703;
Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706;
Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.- UDI-DI
- 00827002577039
- 16076948
- 00827002577060
- 16205108
- 00827002577046
- 16435112
- Lot code
- 16183353X
- 15473203X
- 15476984X
- 15719188X
- 16080161X
Cook Medical Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-Strange, Order Number G09108
- UDI-DI
- 00827002091085
- 15274382
- 15435573
- 15445615
- 15501690
- Lot code
- 15133690X
Product details
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800;
Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809;
Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806;
Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.- UDI-DI
- 00827002448001
- 00827002448094
- 16530788
- 16537255
- 16562522
- 16625687
- 00827002448063
- 00827002448070
- 16625668
- Affected units
- NS16597252, C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, NS16600633, C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, 16530788, 16537255, 16562522, 16625687, C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, NS16523791X, NS16523837X, NS16523837XX, NS16523838, NS16523839, NS16523840, NS16588043, NS16588056, NS16588057, NS16588058, NS16588059, NS16588060, NS16588061, NS16588062, NS16588063, NS16590737, NS16590738, NS16590739, NS16596195, NS16596196, NS16596197, NS16596198, NS16596199, NS16596200, NS16596201, NS16596202, NS16596430, NS16597248, NS16597249, NS16597269, NS16597270, NS16597271, NS16597272, NS16597273, NS16597274, NS16597275, NS16597276, NS16597277, NS16600640, NS16600641, NS16600642, NS16600653, NS16600654, C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, 16625668
Product details
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;
Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;
Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;
Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;
Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;
Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;
Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;
Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;
Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;
Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;
Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;
Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;
Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;
Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;
Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;
Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;
Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;
Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;
Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;
Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;
Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;
Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;
Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;
Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.- UDI-DI
- 00827002439832
- 15569919
- 15520378
- 15487727
- 15484947
- 16617145
- 00827002247543
- 00827002439863
- 00827002439849
- 15557442
- 15520367
- 15518160
- 15594051
- 16576182
- 16617146
- 16622169
- 16642446
- 00827002247529
- 00827002439856
- 16572552
- 00827002439955
- 16505314
- 16554636
- 16559432
- 16572551
- 00827002439962
- 00827002439979
- 00827002508170
- 00827002515376
- 15478180
- 00827002515390
- 16539971
- 00827002440050
- 15628883
- 15496521
- 00827002248038
- 00827002440081
- 16539976
- 00827002440067
- 00827002440074
- 15484937
- 00827002247659
- 00827002478251
- 15550737
- 15553839
- 15565537
- 15520384
- 15655329
- 16514973
- 16535286
- 16554189
- 16556349
- 16580721
- 16584953
- 16625683
- 16625826
- 16634342
- 16636211
- 16636220
- 16639240
- 00827002248090
- 16514972
- 16532975
- 16554638
- 16562523
- 16579251
- 00827002535992
- 15518162
- 15586027
- 00827002478275
- 00827002478299
- 15660266
- 15655331
- 15683408
- 16556179
- 16556350
- 16625673
- 16625817
- 16678414
- 16678420
- 16678428
- 16683763
- 16683788
- 00827002248106
- 15687199
- 16554639
- 16557470
- 16625682
- 16642011
- Lot code
- NS16617419
- NS16617420
- NS16620091
- NS16620092
- NS16620093
- NS16620094
- NS16620414
- NS16620415
- NS16620416
- NS16622160
- NS16622161
- NS16622162
- NS16622163
- NS16622164
- NS16622165
- NS16622166
- NS16622167
- NS16622168
- NS16625835
- NS15668028
- NS15473245
- NS15282739
- NS15282763
- NS15583873
- NS16692824
- NS15583886
- NS15501647
- NS15514024
- NS16534729
- NS15582078
- NS16577963
- NS16454754
- NS16454756
- NS16587983
- NS16612427
- NS16620419
- NS16657119
- NS15660282
- NS15628880
- NS16588033
- NS16493943XX
- NS15643882
- NS15683399
- NS15559871
- NS15597521
- NS15489151
- NS16490614
- NS16493940
- NS16562685
- NS16532973
- NS16537254
- NS16582898
Product details
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685;
Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682;
Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687;
Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.- UDI-DI
- 00827002576858
- 16189446
- 16189593
- 16175956
- 16175957
- 16189597
- 16175953
- 16460934
- 00827002576827
- 16514949
- 16175948
- 00827002576872
- 15151627
- 16131781
- 16471138
- 00827002576865
- 16175951
- 16175949
- 16174015
- 16175955
- 16174023
- 16187746
- 15548776
- 16429827
Cook Medical Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
- UDI-DI
- 00827002320925
- 16120672
- 00827002121157
- 16189604
- 16189588
- 16189603
- 16189608
- 16189589
- 16189602
- 16120666
- 16189594
- Lot code
- NS16200246
- NS16189601
- NS16226797
- NS16200247
- NS16189598
- NS16189586
- NS16189600
- NS16189607
Cook Medical Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
- UDI-DI
- 00827002072428
- Lot code
- NS15796862X
- NS15881832X
Cook Medical Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
- UDI-DI
- 00827002297753
- Lot code
- NS15690755
- NS15408335
Cook Medical Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
- UDI-DI
- 00827002507869
- 15288005
Cook Medical NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
- UDI-DI
- 00827002362505
- 15741134
- 00827002362512
- 15855141
Cook Medical Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
- UDI-DI
- 00827002507876
- 00827002507913
- 15416547
- Lot code
- 15885574X
- 15783003X
Product details
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537;
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537;
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537;
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.- UDI-DI
- 00827002565371
- 15834145
- 15834147
- Lot code
- 15719344X
- 15714808X
Cook Medical Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
- UDI-DI
- 00827002240735
- 16010654
Product details
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424;
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053;
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914;
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431;
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.- UDI-DI
- 00827002564244
- 16288039
- 00827002210530
- 16029543
- 00827002349148
- 15681111
- 15646726
- 15721094
- 15620729
- 15583884
- 15518185
- 15473132
- 15489080
- 15971893
- 15496527
- 15484931
- 15466662
- 15970575
- 16240911
- 16042197
- 16285631
- 16402573
- 16320650
- 15899340
- 16360511
- 16292003
- 16205619
- 16191665
- 16300455
- 16075768
- 16454763
- 16379974
- 15878712
- 15797112
- 15832325
- 15796744
- 15841288
- 00827002444317
- 16256021
- 00827002444324
- 16368587
- 16056219
Recall details
- Company began the recall
- Sold in
Worldwide distribution.
- Company
- Cook IncorporatedBloomington, Indiana
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98495
- Recall numbers
- Z-1775-2026 to Z-1792-2026
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
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
