Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
FDA Device Recall #Z-1111-2026 - Class II, December 19, 2025
Recall Summary
| Recall Number | Z-1111-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 19, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ICU Medical, Inc. |
| Location | San Clemente, CA |
| Product Type | Devices |
| Quantity | 14,684,607 items |
Product Description
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Reason for Recall
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
Distribution Pattern
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.
Lot / Code Information
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), 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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)
Other Recalls from ICU Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2724-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, v1.0.3... | Jun 10, 2026 |
| Z-2723-2026 | Class II | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1)... | Jun 10, 2026 |
| Z-2311-2026 | Class II | Plum Solo Precision IV Pump, 40001-0401 | Apr 29, 2026 |
| Z-2312-2026 | Class II | Plum Duo Infusion Pump, 40002-0401 | Apr 29, 2026 |
| Z-2313-2026 | Class II | Plum Duo Precision IV Pump, 40002-0403 | Apr 29, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.