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GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc Recalls

All product recalls associated with GE OEC Medical Systems, Inc.

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Recall Summary

Total Recalls

1000

Past Year

891

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 4961–4980 of 17593 recalls

OEC 3D Imaging X-Ray System (GE OEC Medical) – Battery Depletion Risk (2021)

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Moderate

FDAJun 10, 2021Nationwide• GE OEC Medical Systems, Inc

OEC Elite Mobile C-arm (GE OEC Medical) – Battery Depletion Issue (2021)

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Moderate

FDAJun 10, 2021Nationwide• GE OEC Medical Systems, Inc

BasixALPHA Inflation Device (Merit Medical) – Handle Separation Risk (2021)

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Moderate

FDA

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Jun 10, 2021

Nationwide

• Merit Medical Systems, Inc.

Lingen Virus Sampling Kit (Mercedes Medical) – No 510(k) Clearance (2021)

No 510(k) clearance

High

FDAJun 10, 2021Nationwide• Mercedes Medical, Inc.

Virus Sampling Kit (Mercedes Medical) - No FDA Clearance (2021)

No 510(k) clearance

High

FDAJun 10, 2021Nationwide• Mercedes Medical, Inc.

Gyrus Acmi PKS Omni (Olympus) - Adhesive Failure Risk (2021)

Fire/Burn Risk

Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.

High

FDAJun 9, 2021Nationwide• Olympus Corporation of the Americas

Advanced Perfusion System 1 (Terumo) - Blender Initialization Fault (2021)

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Moderate

FDAJun 8, 2021IN• Terumo Cardiovascular Systems Corporation

RayStation (RaySearch) - Incorrect Beam Positioning (2021)

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

Moderate

FDAJun 8, 2021TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Mephyton (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Phytonadione Tablets (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Brown Rice Flour (Firebird Artisan Mills) – Salmonella Risk (2021)

Salmonella

Organic Brown Rice Flour has the potential to be contaminated with Salmonella.

Class IIModerate

FDAJun 8, 2021CA, IL, IA +1 more• FO-ND, LLC. (dba Firebird Artisan Mills)

Recirculator 8.0s Kit (Eight Medical) - Aluminum Ion Release Risk (2021)

The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

Moderate

FDAJun 4, 2021Nationwide• Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands

ScanIP Software (Simpleware) - Incorrect Anatomical Orientation (2021)

A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

Low

FDAJun 4, 2021Nationwide• Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Bradninch Hall Castle Street Exeter United Kingdom