Recall archive
197 recalls · page 1 of 9
Reported Sep 16, 2026
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
FDA (weekly enforcement report)
Reported Sep 9, 2026Updated Sep 14, 2026
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow…
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of…
FDA (openFDA device enforcement)
Reported Mar 25, 2026
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in…
FDA (openFDA device enforcement)
Reported Feb 25, 2026
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Pumps were released without full testing being performed, including occlusion alarm testing.
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
FDA (openFDA drug enforcement)
Reported Jan 28, 2026
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the…
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size…
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower…
FDA (openFDA device enforcement)
Reported Oct 22, 2025
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — IV sets may leak.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer…
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP)…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Spectrum IQ Infusion Pump, Product Code 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when…
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Certain Spectrum infusion pumps may have an incorrect version of software.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported May 28, 2025
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported May 21, 2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — A cybersecurity vulnerability was discovered through internal testing.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Welch Allyn Connex Vital Signs Monitor (CVSM):
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing…
9 more products in this recall
FDA (openFDA device enforcement)
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