Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,101–4,150 of 8,689
- Class II
Medical Device Recall · April 17, 2025
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.Incorrect blister labelling.
- Class II
Medical Device Recall · April 17, 2025
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
- Class I
Medical Device Recall · April 17, 2025
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Class II
Medical Device Recall · April 16, 2025
Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer)software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
- Class II
Medical Device Recall · April 16, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic testIt was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
- Class II
Medical Device Recall · April 15, 2025
Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
- Class II
Medical Device Recall · April 15, 2025
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
- Class II
Medical Device Recall · April 15, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
- Class II
Medical Device Recall · April 14, 2025
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screThe perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
- Class II
Medical Device Recall · April 14, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
- Class II
Medical Device Recall · April 14, 2025
Plus Initial Drill, Article Number: 103.170;The referred batch was produced without the laser engraving of 7 mm.
- Class II
Medical Device Recall · April 14, 2025
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site forDue to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
- Class II
Medical Device Recall · April 13, 2025
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139Due to non-sterile products being labeled as sterile
- Class I
Medical Device Recall · April 11, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator, 14mm. Cranial perforator.Inadequate weld that can potentially cause the product to disassemble.
- Class II
Medical Device Recall · April 11, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Class II
Medical Device Recall · April 11, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Class I
Medical Device Recall · April 11, 2025
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- Class I
Medical Device Recall · April 11, 2025
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheterCenterline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
- Class I
Medical Device Recall · April 11, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.Inadequate weld that can potentially cause the product to disassemble.
- Class II
Medical Device Recall · April 11, 2025
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E16During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Class I
Medical Device Recall · April 11, 2025
Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).Potential for the presence of visible foreign matter.
- Class I
Medical Device Recall · April 10, 2025
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-hAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
- Class I
Medical Device Recall · April 10, 2025
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat,Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
- Class II
Medical Device Recall · April 10, 2025
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
- Class I
Medical Device Recall · April 10, 2025
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLIAffected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Class I
Medical Device Recall · April 10, 2025
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
- Class I
Medical Device Recall · April 10, 2025
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Class I
Medical Device Recall · April 10, 2025
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Class I
Medical Device Recall · April 10, 2025
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA EThere is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Class II
Medical Device Recall · April 10, 2025
Contec Medical Systems Co., Ltd.
CMS8000 Patient MonitorPatient monitor has nine identified cybersecurity vulnerabilities.
- Class I
Medical Device Recall · April 10, 2025
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPPumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Class II
Medical Device Recall · April 9, 2025
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
- Class II
Medical Device Recall · April 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile Weitlaner Retractor, Reorder: 67315Three is the potential for the retractors to puncture through the sterile packaging.
- Class II
Medical Device Recall · April 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395Three is the potential for the retractors to puncture through the sterile packaging.
- Class II
Medical Device Recall · April 9, 2025
FoundationOne Companion Diagnostic (F1CDx)Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
- Class II
Medical Device Recall · April 8, 2025
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand InfoDue to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
- Class II
Medical Device Recall · April 8, 2025
Artix MT Thrombectomy Device, REF: 32-102Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
- Class II
Medical Device Recall · April 7, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000USIncorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
- Class II
Medical Device Recall · April 7, 2025
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
- Class II
Medical Device Recall · April 7, 2025
Molding Equipment. WCM series. Model WCM-330GL-iApic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
- Class II
Medical Device Recall · April 7, 2025
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)Vials of implant bone granules may contain less product then specified on labeling.
- Class I
Medical Device Recall · April 7, 2025
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.A cybersecurity vulnerability was discovered through internal testing.
- Class I
Medical Device Recall · April 7, 2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.A cybersecurity vulnerability was discovered through internal testing.
- Class II
Medical Device Recall · April 7, 2025
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
- Class II
Medical Device Recall · April 4, 2025
Integra LifeSciences Corp. (NeuroSciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
- Class II
Medical Device Recall · April 4, 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-contaPotential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Class II
Medical Device Recall · April 4, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology toPreset treatment parameters are not consistently being used in accordance with the IFU.
- Class II
Medical Device Recall · April 4, 2025
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recordingPotential for microbial contamination.
- Class II
Medical Device Recall · April 4, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization ofPotential for microbial contamination.
- Class II
Medical Device Recall · April 4, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates aPotential for internal fastening mechanism within generator of mobile x-Ray to fail.