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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 861–880 of 1,000 recalls

Class IITerminated

Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979

Stryker Spine

The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

May 18, 2021 · DeviceView details →
Class IITerminated

Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745

ADRIA SRL

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

May 17, 2021 · DeviceView details →
Class IITerminated

Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749

ADRIA SRL

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

May 17, 2021 · DeviceView details →
Class IITerminated

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

Cytocell Ltd.

The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

May 17, 2021 · DeviceView details →
Class IITerminated

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

Mediana Co., Ltd.

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

May 17, 2021 · DeviceView details →
Class IITerminated

Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

ADRIA SRL

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

May 17, 2021 · DeviceView details →
Class IITerminated

ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Brainlab AG

Display of potential patient movement might be delayed to the user for high dose treatments.

May 14, 2021 · DeviceView details →
Class IITerminated

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

Smiths Medical ASD Inc.

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

May 14, 2021 · DeviceView details →
Class IITerminated

novaplus, General Purpose Kit, Cat. No. 56603

Medical Action Industries, Inc. 306

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021 · DeviceView details →
Class IITerminated

Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214

Medical Action Industries, Inc. 306

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021 · DeviceView details →
Class IITerminated

Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224

Medical Action Industries, Inc. 306

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021 · DeviceView details →
Class IITerminated

Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209

Medical Action Industries, Inc. 306

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021 · DeviceView details →
Class IITerminated

Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220

Medical Action Industries, Inc. 306

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021 · DeviceView details →
Class IITerminated

EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;

IMPLANTCAST GMBH

A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.

May 10, 2021 · DeviceView details →
Class IITerminated

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

Randox Laboratories Ltd.

Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples

May 10, 2021 · DeviceView details →
Class IITerminated

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

BioFire Diagnostics, LLC

Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

May 10, 2021 · DeviceView details →
Class IITerminated

Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11

Zimmer GmbH

Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree

May 7, 2021 · DeviceView details →
Class IITerminated

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

Beckman Coulter Inc.

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

May 7, 2021 · DeviceView details →
Class IITerminated

Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11

Zimmer GmbH

Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree

May 7, 2021 · DeviceView details →
Class IITerminated

Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.

K2M, Inc

Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

May 7, 2021 · DeviceView details →
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