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Merit Medical Systems, Inc.

Merit Medical Systems, Inc. Recalls

All product recalls associated with Merit Medical Systems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2441–2460 of 3680 recalls

Merit Medical Systems, Inc.: Merit Medical Systems, Inc., Convenience Trays, custom pa...

Surgical gloves in hospital convenience kits may be degraded and tear during use.

FDAMay 19, 2009CO, IN, TX• Merit Medical Systems, Inc.

Stryker Howmedica Osteonics Corp.: Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; N...

Laceration Risk

The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.

FDAMay 15, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 4.3....

In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.

1...121 122123124 125...184

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FDAMay 13, 2009Nationwide• Computerized Medical Systems Inc

Steris Corp: Cmax 110v Surgical Table Hand Control. The Cmax Surgical...

A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out c

FDAMay 12, 2009AL, AR, CA +34 more• Steris Corp

Philips Medical Systems North America Co. Phillips: Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magne...

The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.

FDAMay 12, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Toshiba American Medical Systems Inc: PET-511BTM Multi-plane transesophageal transducer (TEE) u...

Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the PET-511 BTM multi-plane transesophageal transducer (TEE) may result in injury including perforation.

FDAMay 11, 2009Nationwide• Toshiba American Medical Systems Inc

Acist Medical Systems: ACIST Automated Manifold Kit , REF Model BT2000, SKU # 01...

ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.

FDAMay 11, 2009AL, AZ, AR +39 more• Acist Medical Systems

Varian Medical Systems Oncology Systems: Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, ...

Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.

FDAMay 8, 2009Nationwide• Varian Medical Systems Oncology Systems

GE Medical Systems, LLC: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 0...

GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an

FDAMay 8, 2009AL, AK, AZ +34 more• GE Medical Systems, LLC

Stelkast Co: Stelkast Unicondylar Knee Femoral Component SC2462-1. Us...

incorrect size markings on component

FDAMay 5, 2009Nationwide• Stelkast Co

GE Medical Systems, LLC: GE Healthcare, CT Perfusion 4 on Advantage Workstation, C...

GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th

FDAMay 4, 2009AZ, CA, CT +17 more• GE Medical Systems, LLC

GE Medical Systems, LLC: HiSpeed X/i Computed Tomography operator consoles with th...

It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.

FDAMay 1, 2009AL, CA, CT +9 more• GE Medical Systems, LLC

Philips Medical Systems North America Co. Phillips: The product's marketing brochure states: "1.5T coils and ...

Fire/Burn Risk

Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.

FDAMay 1, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Disetronic Medical Systems, Inc.: Roche ACCU-CHEK Spirit insulin pump. Part numbers 454049...

The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.

FDAApr 30, 2009Nationwide• Disetronic Medical Systems, Inc.

Philips Medical Systems (Cleveland) Inc: Dental Application on the Extended Brilliance Workspace v...

Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.

FDAApr 27, 2009AL, AZ, AR +22 more• Philips Medical Systems (Cleveland) Inc

OPTI Medical Systems, Inc: OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), O...

Outer box labeling shows an incorrect storage temperature range.

FDAApr 20, 2009Nationwide• OPTI Medical Systems, Inc

Steris Corp: ASC2000 Ambulatory Surgical Table. Model #MTS110003. T...

Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.

FDAApr 17, 2009AL, AZ, AR +28 more• Steris Corp

Stryker Howmedica Osteonics Corp.: Offset Adaptor Trial - 4MM, Triathlon Revision Instrument...

Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.

FDAApr 16, 2009Nationwide• Stryker Howmedica Osteonics Corp.

GE Medical Systems, LLC: GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system ...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

FDAApr 16, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Signa Ovation 0.35 T MR System. The Signa Ovation Sys...

GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit

FDAApr 16, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC