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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 141–160 of 615 recalls

Class IICompleted

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

Medtronic Neuromodulation

There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

May 27, 2022 · DeviceView details →
Class IICompleted

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Cook Incorporated

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

May 25, 2022 · DeviceView details →
Class IICompleted

illumina Model NextSeq 550 Dx REF 20005715

Illumina, Inc.

cybersecurity vulnerability

May 3, 2022 · DeviceView details →
Class IICompleted

illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

Illumina, Inc.

cybersecurity vulnerability

May 3, 2022 · DeviceView details →
Class IICompleted

CardioTek EP-TRACER Software V2.x.

CardioTek BV

Device did not pass electrical safety testing for adequate insulation.

April 25, 2022 · DeviceView details →
Class IICompleted

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

Philips North America Llc

Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

March 29, 2022 · DeviceView details →
Class IICompleted

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Varian Medical Systems Imaging Laboratory GmbH

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

March 21, 2022 · DeviceView details →
Class IICompleted

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Cardinal Health 200, LLC

Product was distributed without being sterilized.

March 15, 2022 · DeviceView details →
Class IICompleted

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

Augustine Temperature Management, LLC

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

March 14, 2022 · DeviceView details →
Class IICompleted

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management, LLC

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

March 14, 2022 · DeviceView details →
Class IICompleted

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management, LLC

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

March 14, 2022 · DeviceView details →
Class IICompleted

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management, LLC

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

March 14, 2022 · DeviceView details →
Class IICompleted

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

Augustine Temperature Management, LLC

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

March 14, 2022 · DeviceView details →
Class IICompleted

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

Acumed LLC

Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

March 9, 2022 · DeviceView details →
Class IICompleted

4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

Acumed LLC

Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

March 9, 2022 · DeviceView details →
Class IICompleted

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

International Science & Technology, LP, DBA Diamatrix Ltd.

Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".

February 24, 2022 · DeviceView details →
Class IICompleted

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Conformis, Inc.

Incorrect tibial base plate implant packaged in kit

February 22, 2022 · DeviceView details →
Class IICompleted

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Illumina, Inc.

There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

February 22, 2022 · DeviceView details →
Class IICompleted

Destino Twist 14F (also branded as Guidestar 14F)

Oscor Inc.

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

December 22, 2021 · DeviceView details →
Class ICompleted

CovClear COVID-19 Rapid Antigen Test, ATG 900-031

Empowered Diagnostics LLC

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

December 22, 2021 · DeviceView details →
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