Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,451–3,500 of 7,959
- Class II
Medical Device Recall · March 28, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- Class II
Medical Device Recall · March 28, 2025
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- Class II
Medical Device Recall · March 28, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contPotential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- Class II
Medical Device Recall · March 27, 2025
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.Due to a potential open seal in the sterile barrier packaging .
- Class II
Medical Device Recall · March 27, 2025
Skytron Freedom 4FXS-60 Heavy Duty Monitor MountThe mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.
- Class II
Medical Device Recall · March 27, 2025
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewiresDue to a potential open seal in the sterile barrier packaging.
- Class II
Medical Device Recall · March 27, 2025
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into tDue to a potential open seal in the sterile barrier packaging .
- Class II
Medical Device Recall · March 27, 2025
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 008412681Due to a potential open seal in the sterile barrier packaging.
- Class II
Medical Device Recall · March 27, 2025
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vaDue to a potential open seal in the sterile barrier packaging.
- Class II
Medical Device Recall · March 27, 2025
Beckman Coulter DxI 9000 Access Immunoassay AnalyzerWhen DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
- Class I
Medical Device Recall · March 27, 2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire ToriIn response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
- Class II
Medical Device Recall · March 27, 2025
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introducDue to a potential open seal in the sterile barrier packaging .
- Class I
Medical Device Recall · March 27, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
- Class II
Medical Device Recall · March 27, 2025
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devicesDue to a potential open seal in the sterile barrier packaging.
- Class II
Medical Device Recall · March 26, 2025
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aimingAn issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.
- Class II
Medical Device Recall · March 25, 2025
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip SystemThe 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.
- Class II
Medical Device Recall · March 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, UncementedThe 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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Power/Pulsar, Model Number: 781105;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 3.0T, Model Number: 782145;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.
- Class II
Medical Device Recall · March 24, 2025
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 applicationBoston 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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T R11, Model Number: 781170;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T, Model Numbers: 781195 and 781295;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.0T Power/Pulsar, Model Number: 781103;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 1.5T, Model Number: 782146;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.
- Class II
Medical Device Recall · March 24, 2025
MEDLINE INDUSTRIES, LP - Northfield
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Enterprise 1.5T, Model Number: 781145;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.
- Class II
Medical Device Recall · March 24, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains matIt was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
- Class II
Medical Device Recall · March 24, 2025
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, UncementedThe 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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Master/Nova, Model Number: 781106;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.
- Class II
Medical Device Recall · March 24, 2025
Welch Allyn Connex Vital Signs Monitor (CVSM):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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;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.
- Class II
Medical Device Recall · March 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, UncementedThe 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.
- Class II
Medical Device Recall · March 24, 2025
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 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.
- Class II
Medical Device Recall · March 24, 2025
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera CV, Model Number: 781107;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.
- Class II
Medical Device Recall · March 24, 2025
Welch Allyn CONNEX Accessory Power Management Stand: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.
- Class II
Medical Device Recall · March 24, 2025
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, UncementedThe 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.
- Class II
Medical Device Recall · March 24, 2025
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 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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.0T Omni/Stellar, Model Number: 781102;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Omni/Stellar, Model Number: 781104;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 0.5T Standard, Model Number: 781101;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.
- Class II
Medical Device Recall · March 24, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 3.0T Quasar Dual, Model Number: 781150;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.
- Class II
Medical Device Recall · March 24, 2025
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, UncementedThe 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.
- Class II
Medical Device Recall · March 24, 2025
Welch Allyn CP150 Electrocardiograph: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.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class II
Medical Device Recall · March 21, 2025
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class II
Medical Device Recall · March 21, 2025
OEC 3DOEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.