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Tego recallZ-1111-2026 · ICU Medical, Inc. · initiated Dec 19, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

FDA root cause category: Process control

What the company is doing

On 12/19/2025, correction notices were emailed to customers who were asked to do the following: 1) Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the Customer Response Form via email to [email protected] For further inquiries, please contact the firm: Global Complaint Management: [email protected] 1-(866)-216-8806; Customer Service: [email protected], 1-(800)-258-5361

Recall details

Recall number
Z-1111-2026
Status
Open, Classified
Initiated by the company
Dec 19, 2025
Posted by the FDA
Jan 16, 2026
Recalling firm
ICU Medical, Inc.
Quantity
14,684,607 items
Product code
FPA
FDA submissions
K053106
Distribution
Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.

Product description

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

UDI-DI: 00840619026059, 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029), 14044313(6/1/2029), 14228823(12/1/2029), 14274294(1/1/2030); 01C-D1000/14171414(10/1/2029), 14304670(2/1/2030); 055-D1000/13772668(9/1/2028), 13778926(9/1/2028), 13791786(10/1/2028), 13794986(10/1/2028), 13797963(10/1/2028), 13801102(10/1/2028), 13806764(10/1/2028), 13812991(11/1/2028), 13822705(11/1/2028), 13828556(11/1/2028), 13833879(11/1/2028), 13838937(12/1/2028), 13867515(1/1/2029), 13875052(1/1/2029), 13876502(1/1/2029), 13876503(1/1/2029), 13882254(1/1/2029), 13882256(1/1/2029), 13887995(1/1/2029), 13887996(1/1/2029), 13894349(2/1/2029), 13894350(2/1/2029), 13903971(2/1/2029), 13903972(2/1/2029), 14045054(6/1/2029), 14045055(6/1/2029), 14049379(6/1/2029), 14049404(6/1/2029), 14063784(6/1/2029), 14063785(6/1/2029), 14071890(7/1/2029), 14071891(7/1/2029), 14071892(7/1/2029), 14087320(7/1/2029), 14090798(7/1/2029), 14110500(8/1/2029), 14131560(8/1/2029), 14144999(9/1/2029), 14145000(9/1/2029), 14150873(9/1/2029), 14150874(9/1/2029), 14150875(9/1/2029), 14170224(10/1/2029), 14170226(10/1/2029), 14179702(10/1/2029), 14179704(10/1/2029), 14179706(10/1/2029), 14208522(11/1/2029), 14208523(11/1/2029), 14212866(11/1/2029), 14212870(11/1/2029), 14216154(11/1/2029), 14216155(11/1/2029), 14224623(11/1/2029), 14248560(12/1/2029), 14248561(12/1/2029), 14274291(1/1/2030), 1427429291/1/2030), 14278257(1/1/2030), 14278258(1/1/2030), 14278259(1/1/2030), 14278260(1/1/2030), 14300970(2/1/2030), 14300972(2/1/2030), 14303936(2/1/2030); D1000/13768000(9/1/2028), 13772666(9/1/2028), 13778922(9/1/2028), 13778923(9/1/2028), 13778925(9/1/2028), 13791783(10/1/2028), 13791784(10/1/2028), 13791785(10/1/2028), 13792328(10/1/2028), 13794980(10/1/2028), 13794982(10/1/2028), 13794984(10/1/2028), 13801099(10/1/2028), 13801100(10/1/2028), 13801101(10/1/2028), 13806761(10/1/2028), 13806762(10/1/2028), 13806763(10/1/2028), 13812988(11/1/2028), 13812989(11/1/2028), 13812990(11/1/2028), 13822693(11/1/2028), 13822697(11/1/2028), 13822701(11/1/2028), 13825588(11/1/2028), 13828548(11/1/2028), 13828551(11/1/2028), 13828553(11/1/2028), 13833876(11/1/2028), 13833877(11/1/2028), 13833878(11/1/2028), 13838931(11/1/2028), 13838933(12/1/2028), 13838935(11/1/2028), 13848442(12/1/2028), 13848444(12/1/2028), 13848445(12/1/2028), 13854647(12/1/2028), 13854648(12/1/2028), 13854649(12/1/2028), 13858987(12/1/2028), 13859857(12/1/2028), 13859858(12/1/2028), 13859859(12/1/2028), 13867512(1/1/2029), 13867514(1/1/2029), 13876507(1/1/2029), 13876508(1/1/2029), 13876509(1/1/2029), 13882259(1/1/2029), 13882260(1/1/2029), 13887205(1/1/2029), 13887206(1/1/2029), 13887997(1/1/2029), 13894351(1/1/2029), 13894352(2/1/2029), 13894353(2/1/2029), 13903974(2/1/2029), 13903975(2/1/2029), 13903976(2/1/2029), 13903977(2/1/2029), 13910270(2/1/2029), 13910272(2/1/2029), 13938363(3/1/2029), 13938364(3/1/2029), 13938366(3/1/2029), 13943704(3/1/2029), 13943708(3/1/2029), 13943712(3/1/2029), 13943720(3/1/2029), 13949234(3/1/2029), 13953949(3/1/2029), 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14027551(5/1/2029), 14027552(5/1/2029), 14027553(5/1/2029), 14036497(5/1/2029), 14036498(5/1/2029), 14036499(5/1/2029, 14036500(6/1/2029), 14036501(6/1/2029), 14036502(6/1/2029), 14036503(6/1/2029), 14037604(6/1/2029), 14037605(6/1/2029), 14041790(6/1/2029), 14041792(6/1/2029), 14041793(6/1/2029), 14041795(6/1/2029), 14041797(6/1/2029), 14041798(6/1/2029), 14041800(6/1/2029), 14056392(6/1/2029), 14056393(6/1/2029), 14056395(6/1/2029), 14056397(6/1/2029), 14056398(6/1/2029), 14056399(6/1/2029), 14056400(6/1/2029), 14063790(6/1/2029), 14063791(7/1/2029), 14063792(7/1/2029), 14071894(7/1/2029), 14071895(7/1/2029), 14087321(7/1/2029), 14087322(7/1/2029), 14087323(7/1/2029), 14090800(7/1/2029), 14090801(8/1/2029), 14097661(8/1/2029), 14097662(8/1/2029), 14100193(8/1/2029), 14100198(8/1/2029), 14110501(8/1/2029), 14110502(8/1/2029), 14110503(8/1/2029), 14110505(8/1/2029), 14115072(8/1/2029), 14115073(8/1/2029), 14115074(8/1/2029), 14115075(8/1/2029), 14115076(8/1/2029), 14131561(8/1/2029), 14131562(9/1/2029), 14131563(9/1/2029), 14131564(9/1/2029), 14135720(9/1/2029), 14135721(9/1/2029), 14135722(9/1/2029), 14135723(9/1/2029), 14135725(9/1/2029), 14145003(9/1/2029), 14145004(9/1/2029), 14145005(9/1/2029), 14147959(9/1/2029), 14150877(9/1/2029), 14150878(10/1/2029), 14150880(9/1/2029), 14162155(10/1/2029), 14170227(10/1/2029), 14170231(10/1/2029), 14170232(10/1/2029), 14179721(10/1/2029), 14183938(10/1/2029), 14183940(10/1/2029), 14183941(10/1/2029), 14192702(10/1/2029), 14192703(10/1/2029), 14201160(11/1/2029), 14201161(11/1/2029), 14201162(11/1/2029), 14201163(11/1/2029), 14201165(11/1/2029), 14216156(11/1/2029), 14216157(11/1/2029), 14219693(11/1/2029), 14219694(11/1/2029), 14224627(11/1/2029), 14224630(11/1/2029), 14226006(11/1/2029), 14226007(11/1/2029), 14226008(11/1/2029), 14226009(11/1/2029), 14226010(11/1/2029), 14226011(12/1/2029), 14226012(12/1/2029), 14226013(12/1/2029), 14228825(12/1/2029), 14228826(12/1/2029), 14228828(12/1/2029), 14228832(12/1/2029), 14244970(12/1/2029), 14244971(12/1/2029), 1424497(12/1/2029), 14244977(12/1/2029), 14244978(12/1/2029), 14244980(12/1/2029), 14251976(12/1/2029), 14251977(12/1/2029), 14251979(12/1/2029), 14251980(12/1/2029), 14251983(12/1/2029), 14251984(12/1/2029), 14251985(1/1/2030), 14251986(12/1/2029), 14265939(1/1/2030), 14265940(1/1/2030), 14265941(1/1/2030), 14265942(1/1/2030), 14265943(1/1/2030), 14289207(1/1/2030), 14292935(2/1/2030), 14292936(2/1/2030), 14300977(2/1/2030), 14300979(2/1/2030), 14307683(2/1/2030), 14307684(2/1/2030), 14307685(2/1/2030); LAT-D1000/13768003(9/1/2028), 13778927(10/1/2028), 13812992(11/1/2028), 13848447(12/1/2028), 13867516(1/1/2029), 14015450(5/1/2029), 14044312(6/1/2029), 14063789(6/1/2029), 14090799(7/1/2029), 14145002(9/1/2029), 14228820(12/1/2029), 14228821(12/1/2029), 14228822(12/1/2029), 14274293(1/1/2030), 14274302(1/1/2030), 14307682(2/1/2030)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K053106 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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