Recall archive
200 recalls · page 4 of 9
Reported Apr 5, 2023
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or…
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Baxter Electrocardiograph, ELI 380 -DCS21
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Hill-Rom Progressa Bed System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a…
FDA (openFDA device enforcement)
Reported Nov 9, 2022
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices,…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Firm noted an increase in customer reports of leaks.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2022
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product…
FDA (openFDA drug enforcement)
Reported Aug 3, 2022
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Packaging error.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
In-Line ventilator adaptor
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care…
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Firm discovered a firmware memory leak with a supplier-manufactured component.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a potential for foreign matter.
FDA (openFDA device enforcement)
Reported May 4, 2022
PrisMax System, Product Code 955626
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Product is mislabeled as self-righting Luer slip tip caps, yellow.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Compella Bariatric Bed System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
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 the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result…
1 more product in this recall
FDA (openFDA device enforcement)
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