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Recall archive

95,388 stored notices, from Jun 20, 2012 to Nov 11, 2026.

200 recalls · page 1 of 9

Medical devices

Reported Oct 21, 2026Updated Oct 26, 2026

Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Baxter Healthcare Corporation

Matched: Brand — Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where…

FDA (openFDA device enforcement)

Drugs

Reported Oct 7, 2026

Anticoagulant Sodium Citrate 4% w/v Solution USP, 250 mL VIAFLEX Plastic Container Product Code 2B7867Q NDC…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Baxter Healthcare Corporation

Matched: Brand · Reason for recall — Baxter International Inc. is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution (Lot # Y493475) due to the potential presence of…

FDA (weekly enforcement report)

Medical devices

Reported Sep 30, 2026Updated Oct 6, 2026

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Baxter Healthcare Corporation

Matched: Brand — Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to…

2 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 16, 2026Updated Sep 22, 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 (openFDA drug enforcement)

Medical devices

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…

20 more products in this recall

FDA (openFDA device enforcement)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Drugs

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

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