Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 951–1,000 of 7,959
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, KiltPotential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Protective Sleeves.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Kilt Blockers.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Wrap Aprons.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, VestPotential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Caps.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Half Aprons.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Leg Wraps.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Thyroid Shield.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
BD Alaris" System with Guardrails" Suite MX with Point of Care UnitDue to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- Class II
Medical Device Recall · February 10, 2026
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
- Class II
Medical Device Recall · February 10, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemDrill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Class II
Medical Device Recall · February 10, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemDrill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Class II
Medical Device Recall · February 10, 2026
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
- Class II
Medical Device Recall · February 10, 2026
Artegraft Vascular Graft; REF#: AG740;Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Class II
Medical Device Recall · February 9, 2026
Abbott Diagnostics Scarborough, Inc.
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique ComponIt was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · February 9, 2026
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
- Class II
Medical Device Recall · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057Augmentation devices failed bacterial endotoxin testing.
- Class II
Medical Device Recall · February 6, 2026
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)Augmentation devices failed bacterial endotoxin testing.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REThe system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/REThe system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 6, 2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRSoftware anomaly in the patient positioning system may result in positional discrepancy.
- Class II
Medical Device Recall · February 6, 2026
BD Kiestra" ReadA; Catalog No.: 446948.In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
- Class III
Medical Device Recall · February 6, 2026
Battery Charging Station; Model: 0998-00-0802;The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
- Class II
Medical Device Recall · February 6, 2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRSoftware anomaly in the patient positioning system may result in positional discrepancy.
- Class II
Medical Device Recall · February 6, 2026
Artelon FlexBand Plus Ref: 41054 & 41057Augmentation devices failed bacterial endotoxin testing.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01,The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 5, 2026
Campy CVA Medium 100/PK, R01272Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- Class II
Medical Device Recall · February 5, 2026
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative detAfter receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
- Class II
Medical Device Recall · February 4, 2026
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Potential for the Cassette Loading Lever to break.
- Class II
Medical Device Recall · February 4, 2026
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use oThe potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
- Class II
Medical Device Recall · February 4, 2026
React Health PHOENIX 5L Oxygen ConcentratorDevices which did not meet internal quality specifications were inadvertently distributed.
- Class II
Medical Device Recall · February 3, 2026
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05Impactor handle may be missing cross-pin
- Class II
Medical Device Recall · February 3, 2026
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311XImpactor handle may be missing cross-pin
- Class II
Medical Device Recall · February 3, 2026
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LPThere is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- Class II
Medical Device Recall · February 3, 2026
IBA Proton Therapy System - PROTEUS 235It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
- Class II
Medical Device Recall · February 2, 2026
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
- Class II
Medical Device Recall · February 2, 2026
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be usThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Class II
Medical Device Recall · February 2, 2026
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intenThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Class II
Medical Device Recall · February 2, 2026
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation andThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Class II
Medical Device Recall · February 1, 2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Class II
Medical Device Recall · January 30, 2026
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-02There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
- Class II
Medical Device Recall · January 30, 2026
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
- Class II
Medical Device Recall · January 30, 2026
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
- Class II
Medical Device Recall · January 30, 2026
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model NumbeThe instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
- Class II
Medical Device Recall · January 30, 2026
DxC 700 AU, REF: B86444, B86446A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
- Class II
Medical Device Recall · January 30, 2026
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.