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Consumer Product Recalls
127,502 recalls from the U.S. Consumer Product Safety Commission, newest first.
February 19, 2025Medical DevicesFDA
Murata Vios, Inc. recalls Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Hazard: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
February 19, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve
Hazard: Potential that the induction seal is not completely sealed to the device tube packaging.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn
Hazard: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
February 19, 2025Medical DevicesFDA
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic
Hazard: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
February 19, 2025Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System
Hazard: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
February 19, 2025Medical DevicesFDA
HF Acquisition Co LLC recalls Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In
Hazard: Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
February 19, 2025Medical DevicesFDA
Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The
Hazard: Device reaching End of Service prematurely.
February 19, 2025Medical DevicesFDA
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Hazard: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
February 19, 2025Medical DevicesFDA
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Hazard: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DC
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
Hazard: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta
Hazard: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.