Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Certain Spectrum infusion pumps may have an incorrect version of software.
Class IReported ongoing
Distribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
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273 reported ongoing
306 records in this archive. Latest source date Aug 17, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Certain Spectrum infusion pumps may have an incorrect version of software.
Class IReported ongoing
Distribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but...
Class IReported ongoing
Distribution: Worldwide
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but...
Class IReported ongoing
Distribution: Worldwide
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, ...
Class IIReported ongoing
Distribution: US Nationwide distribution.
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Class IIReported ongoing
Distribution: US Nationwide distribution.
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Class IReported ongoing
Distribution: US and Canada
A cybersecurity vulnerability was discovered through internal testing.
Class IReported ongoing
Distribution: Worldwide distribution.
A cybersecurity vulnerability was discovered through internal testing.
Class IReported ongoing
Distribution: Worldwide distribution.
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIReported ongoing
Distribution: Worldwide distribution.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV flui...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 306 records, including 273 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.