Baxter Healthcare Corporation recalled 958,351 CLEARLINK CONTINU-FLO IV sets due to a leak risk. The non-vented sets feature three Luer activated valves and a Backcheck Valve. Distribution covered nationwide in the United States. Healthcare providers and patients should stop using the device immediately and follow recall instructions on the recall notice.
IV sets may leak.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
IV administration sets are used to deliver fluids and medications via IV lines in medical settings. The CLEARLINK CONTINU-FLO solution set is a non-vented configuration with three valves and a retractable collar.
Leakage in IV sets can compromise fluid delivery and potentially expose patients to IV fluids or medications.
This recall is not indicated as part of a broader industry pattern in the provided data.
Hospitals and clinics distributing these units nationwide may need to replace affected sets to ensure safe IV therapy; 958,351 units were distributed.
FDA recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0193-2026
Typically 4-8 weeks for refunds or replacements
Keep the recall notice, model numbers, date codes, and all correspondence with Baxter or suppliers
Model numbers and product code: 2C8537. UDI/DI 00085412048970. Model numbers include R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024. Sold nationwide in the US through hospitals and medical facilities. Sold since unspecified date. Product Code 2C8537. Price not disclosed.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Baxter Healthcare recalled five infusion pumps on January 13, 2026. The pumps were released without full testing, including critical occlusion alarm checks. Healthcare providers and patients must stop using the device immediately.
Baxter Healthcare recalled 585 SIGMA Spectrum Infusion Pumps on November 28, 2025, due to a defect that may cause over-infusion. The affected model is the 35700BAX2, which has been distributed nationwide. Users must stop using the device immediately and follow recall instructions.
Baxter Healthcare recalled 118 units of the Welch Allyn INF BAG, Model REF 5089-18, on October 28, 2025. The replacement bladder may contain a Large Adult size bladder instead of a Thigh size bladder. This defect poses a high risk for inaccurate blood pressure readings.
Baxter Healthcare recalled 5,209 oral/axillary probes used with Welch Allyn SureTemp Plus thermometers nationwide in the United States, Canada and Colombia. The probes were inadvertently programmed with the rectal configuration, which can yield a lower temperature reading. Healthcare providers and patients should stop using the affected probes immediately and follow Baxter’s recall instructions.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Baxter Healthcare Corp. recalled 12,720 CLEARLINK SYSTEM CONTINU-FLO IV sets distributed nationwide to healthcare facilities. The devices may leak during use. Hospitals and clinicians should stop using immediately and follow Baxter's recall instructions.
Baxter Healthcare recalled 1,167,120 CLEARLINK CONTIN-FLO IV Solution Sets nationwide after determining they may leak. The non-vented sets include three CLEARLINK Luer Activated Valves and a backcheck valve. Healthcare providers and patients should stop using these devices immediately and contact Baxter for instructions.
Baxter Healthcare recalled 69,936 CLEARLINK System Non_DEHP Extension Sets sold nationwide to hospitals and clinics. The IV extension sets may leak. Healthcare providers should stop using the device and follow Baxter's recall instructions.