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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 4161–4180 of 39,430 recalls

Class IIOngoing

Allura Xper FD20/20 System Code: (1) 722038

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · DeviceView details →
Class IIOngoing

Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · Device
View details →
Class IOngoing

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IIOngoing

Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/10; Catalog numbers: 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10C; Catalog number: 722001

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IIOngoing

AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD10C System Code: (1) 722001

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/20; Catalog numbers: 722038

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IIOngoing

Brand 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 weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

Integra LifeSciences Corp.

Potential that the induction seal is not completely sealed to the device tube packaging.

January 10, 2025 · DeviceView details →
Class IOngoing

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Fresenius Kabi USA, LLC

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

January 10, 2025 · DeviceView details →
Class IOngoing

Intact 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: 156080062

Spectranetics Corporation

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.

January 10, 2025 · DeviceView details →
Class IIOngoing

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

January 10, 2025 · DeviceView details →
Class IIOngoing

BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

CareFusion 303, Inc.

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

January 10, 2025 · DeviceView details →
Class IIOngoing

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

Nobel Biocare

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

January 10, 2025 · DeviceView details →
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