Recall archive
200 recalls · page 3 of 9
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)
Reported Apr 10, 2024
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter…
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's…
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 Recall for the Hip Distraction System, Traction Boot II, due to the boots being…
FDA (openFDA device enforcement)
Reported Mar 20, 2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Baxter Exactamix Pro 1200, REF EXM12DY
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Failed pH Specifications
FDA (openFDA drug enforcement)
Reported Nov 15, 2023
Novum IQ Syringe infusion system, Product Code 40800BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion…
FDA (openFDA device enforcement)
Reported Nov 8, 2023
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator…
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
FDA (openFDA drug enforcement)
Reported Oct 4, 2023
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software…
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Welch Allyn Connex Spot Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 30, 2023
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
FDA (openFDA drug enforcement)
Reported Jul 26, 2023
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on…
FDA (openFDA device enforcement)
Reported Jul 19, 2023
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 10, 2023
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
FDA (openFDA device enforcement)
Reported May 3, 2023
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The product is brittle and potentially crumbling upon handling or when being removed from its package.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
FDA (openFDA device enforcement)
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