Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,151–4,200 of 8,689
- Class II
Medical Device Recall · April 3, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 88The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Class II
Medical Device Recall · April 3, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5)The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Class II
Medical Device Recall · April 3, 2025
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operatorPotential for exoskeleton to lose lateral balance and cause patient to fall.
- Class II
Medical Device Recall · April 3, 2025
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
- Class II
Medical Device Recall · April 3, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5)The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Class II
Medical Device Recall · April 3, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
- Class II
Medical Device Recall · April 3, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Class II
Medical Device Recall · April 2, 2025
Leica Biosystems Melbourne Pty Ltd
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tisThere is a leakage issue associated with the tubing in the manifold of the instrument.
- Class II
Medical Device Recall · April 2, 2025
Washer Disinfector Aquadis 56; Model Number: 56MThe frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
- Class II
Medical Device Recall · April 2, 2025
Washer Disinfector Aquadis 56; Model Number: 56AThe frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
- Class II
Medical Device Recall · April 2, 2025
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arcDue to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
- Class II
Medical Device Recall · April 1, 2025
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
- Class II
Medical Device Recall · April 1, 2025
myQA iON; Article Number: MQ10-000;Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
- Class II
Medical Device Recall · March 31, 2025
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
- Class II
Medical Device Recall · March 31, 2025
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-0Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Class II
Medical Device Recall · March 31, 2025
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 LitePotential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Class II
Medical Device Recall · March 31, 2025
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). ThPotential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
- Class II
Medical Device Recall · March 31, 2025
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
- Class II
Medical Device Recall · March 31, 2025
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-0003Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Class II
Medical Device Recall · March 31, 2025
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning systemDuring routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
- Class II
Medical Device Recall · March 31, 2025
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience KitAn issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
- Class II
Medical Device Recall · March 31, 2025
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
- Class II
Medical Device Recall · March 28, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 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 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 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 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
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 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 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
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
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
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 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 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 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 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
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
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
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
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 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
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
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 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
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.