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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 3581–3600 of 39,430 recalls

Class IIOngoing

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

Conformis Inc.

The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.

March 25, 2025 · DeviceView details →
Class IIOngoing

Intera 1.5T Master/Nova, Model Number: 781106;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Welch Allyn Connex Vital Signs Monitor (CVSM):

Baxter Healthcare Corporation

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

March 24, 2025 · DeviceView details →
Class IIOngoing

SmartPath to dStream for 3.0T, Model Number: 782145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

Boston Scientific Corporation

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

March 24, 2025 · DeviceView details →
Class IIOngoing

Welch Allyn CONNEX Accessory Power Management Stand:

Baxter Healthcare Corporation

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

March 24, 2025 · DeviceView details →
Class IIOngoing

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Zimmer, Inc.

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

March 24, 2025 · DeviceView details →
Class IIOngoing

SmartPath to dStream for 1.5T, Model Number: 782146;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

Boston Scientific Corporation

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 1.0T Omni/Stellar, Model Number: 781102;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

MEDLINE INDUSTRIES, LP - Northfield

A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.

March 24, 2025 · DeviceView details →
Class IIOngoing

Enterprise 1.5T, Model Number: 781145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

Boston Scientific Corporation

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

March 24, 2025 · DeviceView details →
Class IIOngoing

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Zimmer, Inc.

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 1.5T Omni/Stellar, Model Number: 781104;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 0.5T Standard, Model Number: 781101;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 3.0T Quasar Dual, Model Number: 781150;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Intera 1.5T Power/Pulsar, Model Number: 781105;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025 · DeviceView details →
Class IIOngoing

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Zimmer, Inc.

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

March 24, 2025 · DeviceView details →
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