Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAzurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAzurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAzurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAzurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAzurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD10C; Catalog number: 722001
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura CV20; Catalog numbers: 722031
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20/20; Catalog numbers: 722038
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20/15; Catalog numbers: 722058
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20/10; Catalog numbers: 722029
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IAllura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceSpectranetics CorporationClass IIntact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 15608006
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
- 2025-02-19FDA-DeviceHologic, IncClass IIBrand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- 2025-02-19FDA-DeviceMurata Vios, Inc.Class IIVios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
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.
- 2025-02-19FDA-DeviceIntegra LifeSciences Corp.Class IIBrand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weigh
Potential that the induction seal is not completely sealed to the device tube packaging.
- 2025-02-19FDA-DeviceExactech, Inc.Class IIAlteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- 2025-02-19FDA-DeviceExactech, Inc.Class IINovation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- 2025-02-19FDA-DeviceExactech, Inc.Class IIAcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM 140-36-30 AM EHXL 0¿ LNR K 36MM 140-28-25 AM EHXL 0¿LNR E 28MM 140-28-26 AM EHXL 0¿LNR F 28MM 140-28-28 AM EHXL 0¿LNR H 28MM 140-36-28 AM EHXL 0¿LNR H 36MM 140-28-30 AM EHXL 0¿LNR K 28MM 142-28-24 AM EHXL 15¿ LNR
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- 2025-02-19FDA-DeviceMicrobiologics IncClass IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
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.
- 2025-02-19FDA-DeviceMicrobiologics IncClass IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
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.
- 2025-02-19FDA-DeviceElekta, Inc.Class IIMOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
- 2025-02-19FDA-DeviceHF Acquisition Co LLCClass IIBiological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
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.
- 2025-02-19FDA-DeviceAngel Medical Systems, Inc.Class IIBrand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.
Device reaching End of Service prematurely.
- 2025-02-19FDA-DeviceStryker CorporationClass IIstryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- 2025-02-19FDA-DeviceStryker CorporationClass IIstryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
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