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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

893

Class I (Serious)

124

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 15281–15300 of 17593 recalls

Merit Medical Systems, Inc.: Custom Waste Management Kit, K10-01756/B, Sterile EO, Mer...

Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.

FDASep 12, 2008Nationwide• Merit Medical Systems, Inc.

Community Products, LLC: Toddler Chair Hip Strap (Belt). The hip belt is made with...

Choking Hazard

Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.

FDASep 12, 2008Nationwide• Community Products, LLC

Philips Medical Systems: M3811B Philips Telemonitoring Clinical Review Software pa...

1...763 764765766 767...880

Page 765 of 880Next

Multiprint report may contain incorrect vital data for patients

FDASep 11, 2008Nationwide• Philips Medical Systems

Beckman Coulter Inc.: Access Immunoassay Systems Assay Protocol File (APF) Soft...

The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.

FDASep 11, 2008Nationwide• Beckman Coulter Inc.

Philips Medical Systems North America Co. Phillips: Philips BV Endura Mobile X-Ray system with the extended r...

The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions.

FDASep 10, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Philips BV Pulsera Mobile X-Ray system with the extended ...

FDASep 10, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Barcoview 35 President Kennedy Park Kortrijk Belgium: Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC...

The front protective cover may loosen and completely fall off.

FDASep 9, 2008Nationwide• Barcoview 35 President Kennedy Park Kortrijk Belgium

Bk Medical Mileparken 34 Iierlev Denmark: Single-use sterile puncture attachment UA1256-U used with...

No 510k approved

FDASep 8, 2008Nationwide• Bk Medical Mileparken 34 Iierlev Denmark

GE Medical Systems, LLC: GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY ...

There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.

FDASep 8, 2008AL, AK, AZ +44 more• GE Medical Systems, LLC

ConMed Corporation: VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) S...

The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.

FDASep 8, 2008Nationwide• ConMed Corporation

J T Posey Company: Posey Connecting Straps & Belts/Locking Cuffs. The dev...

The recall was initiated after an investigation conducted by the Posey Company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. In some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.

FDASep 8, 2008Nationwide• J T Posey Company

Stryker Communications Corp: Circlip component of the Stryker Flat Panel and Navigatio...

Circlip component used to suspend flat panel and navigation arm system may become dislodged.

FDASep 5, 2008Nationwide• Stryker Communications Corp

Philips Medical Systems North America Co. Phillips: Philips BV Pulsera R2.2 Mobile X-ray system. The Type Pr...

Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor

FDASep 5, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Philips BV Endura R2.2 Mobile X-ray system. The Type Pro...

FDASep 5, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Gebauer Company: Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Ski...

Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user.

FDASep 3, 2008Nationwide• Gebauer Company

Gas Ranges (Wolf Appliance) – burn hazard (2008)

Fire/Burn Risk

This recall involves the following Wolf Appliance 48-Inch gas ranges with model numbers: P48, PS48 and R48. The gas ranges are stainless steel with a double oven. A "Wolf" appliance logo is on the front of the larger oven door.

CPSCSep 3, 2008Nationwide• Wolf Appliance Inc., of Madison, Wis.

Action Baby Carriers (Optave) – fall hazard (2008)

The recalled carriers were sold under the "Action Baby Carrier" brand name. The carriers are sold in various colors and patterns: blue, brown, green, "so square", "the larrisa" and "spring breeze."

CPSCSep 3, 2008Nationwide• Optave Inc., of Alpena, Mich.

Stryker Communications Corp: Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (I...

Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Communications Corporation by telephone at 97

FDASep 2, 2008Nationwide• Stryker Communications Corp

GE Medical Systems, LLC: GE Healthcare, Drapes and Sterile Covers PART NUMBER ...

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

FDAAug 29, 2008Nationwide• GE Medical Systems, LLC

Philips Healthcare Informatics, Inc.: iSite PACS (Picture Archiving and Communication System), ...

Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot

FDAAug 29, 2008CO, MN, PA• Philips Healthcare Informatics, Inc.