Recall archive
197 recalls · page 2 of 9
Reported Apr 2, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
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 missing motor mounting screws, which may have occurred during the servicing process.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Devices were identified as released after repair without full testing being performed, which includes flow testing.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
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 aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is…
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 aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but…
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
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 Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product details — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA (openFDA drug enforcement)
Reported Aug 28, 2024
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
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 Correction for the PST 500 U Precision Surgical Table due to a potential issue with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery…
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to…
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 the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on…
FDA (openFDA device enforcement)
Reported May 22, 2024
Spectrum IQ Infusion pump, Product Code 357009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a potential for cracks on the mount of the front panel of the device.
FDA (openFDA device enforcement)
Reported May 15, 2024
Baxter 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 · Product · Product details — One device was improperly performed testing prior to release from a Service Center.
FDA (openFDA device enforcement)
Reported May 1, 2024
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Product was distributed in the United States without proper regulatory approval.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements…
2 more products in this recall
FDA (openFDA device enforcement)
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