Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 1,701–1,750 of 8,689
- 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 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 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 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 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 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 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 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
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 1Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- 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.
- 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
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
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
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge,The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
- Class II
Medical Device Recall · January 30, 2026
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58There 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
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 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervationDue to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPIDB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervationDue to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: NoB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Olympus Corporation of the Americas
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent lPotential for rubber fragment detachment during use.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: NoB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: NoB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: NoB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 ComponeB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: NoB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Class II
Medical Device Recall · January 29, 2026
Olympus Corporation of the Americas
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent refPotential for rubber fragment detachment during use.
- Class II
Medical Device Recall · January 28, 2026
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXCFabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
- Class II
Medical Device Recall · January 28, 2026
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
- Class II
Medical Device Recall · January 28, 2026
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGNFabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
- Class I
Medical Device Recall · January 27, 2026
Impella RP. Product Code: 0046-0011.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Class II
Medical Device Recall · January 27, 2026
CLARITY II Laser System; Model No. 1110200210.Reports of devices sparking/popping and potentially burning patients.
- Class I
Medical Device Recall · January 27, 2026
Impella RP Flex with SmartAssist. Product Code: 1000323.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Class II
Medical Device Recall · January 27, 2026
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- Class I
Medical Device Recall · January 27, 2026
Impella RP with SmartAssist. Product Code: 0046-0035.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 26, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.XUnder certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Class II
Medical Device Recall · January 23, 2026
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).