ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
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;…
Read the official notice →- Date
- 2026-01-28
- Country
- United States
- Brand
- ICU Medical
- Product
- Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of FL, AZ, RI,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ICU Medical recalls
- 2026-06-17
USICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA,…Official notice →- 2026-05-27
- US
ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer…
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy…
FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX,…Official notice → - 2026-01-28
- US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Philippines.Official notice → - 2026-01-21
- US
ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage…
FDA · DeviceICU Medical Inc.US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO,…Official notice → - US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number 40002-04-01
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible…
- 2025-12-31
- US
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they…
FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2026-01-28
- US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Philippines.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system; Software Version Number: R3.1;
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR,…Official notice → - US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni…
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…Official notice → - US
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025,…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material…
FDA · DeviceRAYSEARCH LABORATORIES ABRefer to the attached documents: Distribution list 167168 US - updated,…Official notice → - US
Medline Industries, LP recalls MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an…
- US
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed…
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules