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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Various Cook Medical Devices Recalled for Incorrect Expiration Dates

Agency Publication Date: April 6, 2026
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Summary

Cook Incorporated is recalling approximately 12,434 medical devices across multiple product lines, including various catheters, introducer sets, and wire guides. The affected products were labeled with expiration dates that exceed their validated shelf life. No incidents or injuries have been reported to date, but the company is initiating this voluntary recall to ensure patient safety. These devices were distributed worldwide to authorized medical distributors, hospitals, and healthcare facilities.

Risk

Using these medical devices beyond their true shelf life may result in compromised device performance or loss of sterility. Because these items are used in critical medical procedures like tracheostomies and venous access, a failure could lead to procedural delays or patient infections.

What You Should Do

  1. Identify if you have any of the affected Cook Medical devices by checking the reference part numbers, order numbers, and lot numbers on your product packaging.
  2. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical devices immediately and quarantine any remaining stock in your facility.
  4. Contact Cook Medical or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled devices. Contact Cook Medical or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.

Affected Products

Product: COOK MEDICAL Approach CTO-6 Micro Wire Guide
Model / REF:
CMW-14-190-6G
G50786
Lot Numbers:
15288005
UDI:
00827002507869

Recall #: Z-1775-2026; Quantity: 15 units

Product: COOK MEDICAL Approach CTO-12 Micro Wire Guide
Model / REF:
CMW-14-190-12G
G50787
CMW-14-300-12G
G50791
Lot Numbers:
15885574X
15783003X
15416547
UDI:
00827002507876
00827002507913

Recall #: Z-1776-2026; Quantity: 49 units

Product: COOK MEDICAL Approach CTO-18 Micro Wire Guide
Model / REF:
CMW-14-190-18G
G50788
CMW-14-300-18G
G50792
Lot Numbers:
15898546X
15660224
15220204
UDI:
00827002507883
00827002507920

Recall #: Z-1777-2026; Quantity: 75 units

Product: COOK MEDICAL Arterial Pressure Monitoring Tray
Model / REF:
APMY-2.5-15-0-2.5
G58412
APMY-4.0-21J-1-12
G58419
Lot Numbers:
15894185X
15747314X
15264260X
UDI:
00827002584129
00827002584198

Recall #: Z-1778-2026; Quantity: 20 units

Product: COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set
Model / REF:
C-PTIS-100-HC-G-EU
G57685
C-PTIS-100-HC-G-NA
G57682
C-PTIS-100-UNL-HC-G-EU
G57687
C-PTIS-100-UNS-HC-G-EU
G57686
Lot Numbers:
16189446
16189593
16175956
16175957
16189597
16175953
16460934
16514949
16175948
15151627
16131781
16471138
16175951
16175949
16174015
16175955
16174023
16187746
15548776
16429827
UDI:
00827002576858
00827002576827
00827002576872
00827002576865

Recall #: Z-1779-2026; Quantity: 916 units

Product: COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray
Model / REF:
C-PTISY-100-HC-G-NA
G57703
C-PTISY-100-UNL-HC-G-NA
G57706
C-PTISY-100-UNS-HC-G-NA
G57704
Lot Numbers:
16183353X
16076948
15473203X
15476984X
15719188X
16205108
16080161X
16435112
UDI:
00827002577039
00827002577060
00827002577046

Recall #: Z-1780-2026; Quantity: 441 units

Product: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set
Model / REF:
C-PTIS-100-FLEX-HC
G32092
C-PTIS-100-HC
G12115
Lot Numbers:
NS16200246
NS16189601
NS16226797
NS16200247
NS16189598
NS16189586
NS16189600
16120672
NS16189607
16189604
16189588
16189603
16189608
16189589
16189602
16120666
16189594
UDI:
00827002320925
00827002121157

Recall #: Z-1781-2026; Quantity: 484 units

Product: COOK MEDICAL Cook Staged Extubation Set
Model / REF:
C-CAE-14.0-83-EXTU
G24073
Lot Numbers:
16010654
UDI:
00827002240735

Recall #: Z-1782-2026; Quantity: 95 units

Product: COOK MEDICAL Cook Spectrum Central Venous Catheter Tray
Model / REF:
C-UTLMY-701J-ABRM-CUSTOM-0003
G56424
C-UTLMY-701J-ABRM-CUSTOM-0018
G21053
C-UTLMY-701J-ABRM-CUSTOM-0042
G34914
C-UTLMY-701J-ABRM-CUSTOM-0047
G44431
C-UTLMY-701J-ABRM-CUSTOM-0048
G44432
Lot Numbers:
16288039
16029543
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
16256021
16368587
16056219
UDI:
00827002564244
00827002210530
00827002349148
00827002444317
00827002444324

Recall #: Z-1783-2026; Quantity: 1872 units

Product: COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set
Model / REF:
C-CSRC-7.5D-40-STRANGE
G09108
Lot Numbers:
15133690X
15274382
15435573
15445615
15501690
UDI:
00827002091085

Recall #: Z-1784-2026; Quantity: 49 units

Product: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set
Model / REF:
C-TCCSB-500-UNI
G32193
C-TCCSB-500-UNI-01
G47665
Lot Numbers:
NS16189671
16191668
16195472
16195467
16191666
16191677
16191661
16200360
16185929
16237917
16191674
16191671
16193388
16193387
16191667
16195473
16191662
16191689
16195468
16271019
UDI:
00827002321939
00827002476653

Recall #: Z-1785-2026; Quantity: 476 units

Product: COOK MEDICAL Multipurpose Drainage Catheter
Model / REF:
ULT8.5-38-25-P-CLMS-8-RH-FS
G29775
Lot Numbers:
NS15690755
NS15408335
UDI:
00827002297753

Recall #: Z-1786-2026; Quantity: 20 units

Product: COOK MEDICAL NCompass Nitinol Stone Extractor
Model / REF:
C-NTSE-2.4-115-NC3
G36250
C-NTSE-2.4-115-NCT4
G36251
Lot Numbers:
15741134
15855141
UDI:
00827002362505
00827002362512

Recall #: Z-1787-2026; Quantity: 70 units

Product: COOK MEDICAL Spectrum Central Venous Catheter Set
Model / REF:
C-UDLM-401J-ABRM-HC
G43983
C-UDLM-401J-ABRM-HC-CAH
G24754
C-UDLM-401J-LSC-ABRM-HC
G43986
C-UDLM-401J-PED-ABRM-HC
G43984
C-UDLM-401J-PED-ABRM-HC-CAH
G24752
C-UDLM-401J-RSC-ABRM-HC
G43985
C-UDLM-501J-ABRM-HC
G43995
C-UDLM-501J-PED-ABRM-HC
G43996
C-UDLM-501J-RSC-ABRM-HC
G43997
C-UDLM-801J-ABRM-HC
G50817
C-UQLM-1001J-ABRM-HC-RD
G51537
C-UQLM-1001J-RSC-ABRM-HC-RD
G51539
C-UTLM-501J-ABRM-HC
G44005
C-UTLM-501J-ABRM-HC-CAH
G24803
C-UTLM-501J-LSC-ABRM-HC
G44008
C-UTLM-501J-PED-ABRM-HC
G44006
C-UTLM-501J-RSC-ABRM-HC
G44007
C-UTLM-501J-RSC-ABRM-HC-CAH
G24765
C-UTLM-701J-ABRM-HC-RD
G47825
C-UTLM-701J-ABRM-HC-RD-CAH
G24809
C-UTLM-701J-ABRM-HC-RD-P
G53599
C-UTLM-701J-LSC-ABRM-HC-RD
G47827
C-UTLM-701J-RSC-ABRM-HC-RD
G47829
C-UTLM-701J-RSC-ABRM-HC-RD-CAH
G24810
Lot Numbers (79):
15569919
15520378
15487727
15484947
16617145
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
15557442
15520367
15518160
15594051
16576182
16617146
16622169
16642446
NS15583886
NS15501647
NS15514024
NS16534729
16572552
16505314
16554636
16559432
16572551
NS15582078
NS16577963
NS16454754
UDI:
00827002439832
00827002247543
00827002439863
00827002439849
00827002247529
00827002439856
00827002439955
00827002439962
00827002439979
00827002508170
00827002515376
00827002515390
00827002440050
00827002248038
00827002440081
00827002440067
00827002440074
00827002247659
00827002478251
00827002248090
00827002535992
00827002478275
00827002478299
00827002248106

Recall #: Z-1788-2026; Quantity: 5080 units

Product: COOK MEDICAL Spectrum Central Venous Tray
Model / REF:
C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD
G44800
C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD
G44809
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD
G44806
C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD
G44807
Lot Numbers:
NS16597252
NS16600633
16530788
16537255
16562522
16625687
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
16625668
UDI:
00827002448001
00827002448094
00827002448063
00827002448070

Recall #: Z-1789-2026; Quantity: 2348 units

Product: COOK MEDICAL Thal-Quick Chest Tube Tray
Model / REF:
C-TQTSY-3200
G07242
Lot Numbers:
NS15796862X
NS15881832X
UDI:
00827002072428

Recall #: Z-1790-2026; Quantity: 2 units

Product: COOK MEDICAL Wayne Pneumothorax Set
Model / REF:
C-UTPT-1020-WAYNE-IMH
G56532
C-UTPT-1400-WAYNE-112497-IMH
G56535
Lot Numbers:
15719344X
15714808X
15834145
15834147
UDI:
00827002565371

Recall #: Z-1791-2026; Quantity: 104 units

Product: COOK MEDICAL Wayne Pneumothorax Tray
Model / REF:
C-UTPTY-1400-WAYNE-112497-IMH
G56537
Lot Numbers:
15719344X
15714808X
15834145
15834147
UDI:
00827002565371

Recall #: Z-1792-2026; Quantity: 318 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98495
Status: Active
Manufacturer: Cook Incorporated
Sold By: Authorized Medical Distributors; Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 18 products (15 units; 49 units; 75 units; 20 units; 916 units; 441 units; 484 units; 95 units; 1872 units; 49 units; 476 units; 20 units; 70 units; 5080 units; 2348 units; 2 units; 104 units; 318 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.