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Omega Medical Imaging, Inc.

Omega Medical Imaging, Inc. Recalls

All product recalls associated with Omega Medical Imaging, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 3561–3580 of 25002 recalls

Omega Monitor Suspension (Omega Medical) – Boom Detachment (2023)

An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.

Moderate

FDASep 8, 2023AL, CA, IL +8 more• Omega Medical Imaging, Inc.

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

Moderate

FDASep 8, 2023Nationwide• GE Medical Systems China Co., Ltd. National Hi-Tech No.

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Class I

1...177 178179180 181...1251

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High

FDASep 8, 2023Nationwide• Novartis Pharmaceuticals Corp.

Commercial Clothes Dryers (Whirlpool) – Fire hazard (2023)

Fire/Burn Risk

This recall involves all ADC brand stacked commercial clothes dryers with a 30 lb. capacity and model number ADG-30X2R or ADG-30X2Ri. Both models were sold in on-premise and coin-operated configurations for multi-unit housing, laundromats, and other facilities that use commercial laundry equipment. Logos and branding may appear differently depending on when the unit was manufactured. The model number for each unit is printed inside near the hinges of the upper door. The ADG-30X2R units were also sold in custom colors other than white to fit location branding.

High

CPSCSep 7, 2023Nationwide• Whirlpool Corporation, of Benton Harbor, Michigan

Cequa Eye Solution (Sun Pharmaceutical) – Subpotent Medication (2023)

Subpotent: Out of Specification result observed for low assay

Class IIILow

FDASep 7, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

RX Monaco Analyzer (Randox) – Rerun Setting Failure (2023)

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

Moderate

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Venue Go Standard Cart (GE Medical) – Tilt Mechanism Failure (2023)

Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

High

FDASep 6, 2023Nationwide• GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.

RX Daytona Plus Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

Moderate

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

AU/DxC Chemistry Transferrin (Beckman Coulter) – stability claims issue (2023)

The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.

Moderate

FDASep 6, 2023Nationwide• Beckman Coulter Biomedical Division Lismeehan, O'Callaghan's Mills County Clare Ireland

Roasted Salted Pecan Halves (Lipari Foods) – Mislabeled nuts (2023)

Top label says Roasted Salted Pecan Halves, but product is actually filberts / hazelnuts

Class IIModerate

FDASep 6, 2023FL, IL, IN +5 more• Lipari Foods Operating Company, LLC.

Oasis Dry Suction Water Seal Chest Drain (Atrium) – unauthorized reprocessing (2023)

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

Moderate

FDASep 5, 2023VA• Atrium Medical Corporation

Pantoprazole Sodium Injection (BE Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Class IIModerate

FDASep 5, 2023Nationwide• BE PHARMACEUTICALS AG

Life Is Peachy Ice Cream (Life Raft) – Listeria contamination (2023)

Listeria

South Carolina Department of Health discovered the product contained Listeria monocytogenes.

Class IHigh

FDASep 5, 2023DC• Life Raft Treats Ice Cream Factory

Ice Cream Not Fried Chicken (Life Raft) – Listeria contamination (2023)

Listeria

South Carolina Department of Health discovered the product contained Listeria monocytogenes.

Class IHigh

FDASep 5, 2023DC• Life Raft Treats Ice Cream Factory

Guardian System (Angel Medical) – premature service end (2023)

Device reaching End of Service prematurely.

High

FDASep 1, 2023Nationwide• Angel Medical Systems, Inc.

LAVH Pack (American Contract) – component investigation (2023)

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

Moderate

FDASep 1, 2023Nationwide• American Contract Systems, Inc.

Breast Plastics Pack (American Contract) – component investigation (2023)

Moderate

FDASep 1, 2023Nationwide• American Contract Systems, Inc.

Stay Informed

Omega Medical Imaging, Inc. Recalls

Recall Summary

Omega Monitor Suspension (Omega Medical) – Boom Detachment (2023)

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Commercial Clothes Dryers (Whirlpool) – Fire hazard (2023)

Cequa Eye Solution (Sun Pharmaceutical) – Subpotent Medication (2023)

RX Monaco Analyzer (Randox) – Rerun Setting Failure (2023)

Venue Go Standard Cart (GE Medical) – Tilt Mechanism Failure (2023)

RX Daytona Analyzer (Randox) – Rerun Setting Failure (2023)

RX Imola Analyzer (Randox) – Rerun Setting Failure (2023)

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

RX Daytona Plus Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

AU/DxC Chemistry Transferrin (Beckman Coulter) – stability claims issue (2023)

Roasted Salted Pecan Halves (Lipari Foods) – Mislabeled nuts (2023)

Oasis Dry Suction Water Seal Chest Drain (Atrium) – unauthorized reprocessing (2023)

Pantoprazole Sodium Injection (BE Pharmaceuticals) – Sterility Concern (2023)

Life Is Peachy Ice Cream (Life Raft) – Listeria contamination (2023)

Ice Cream Not Fried Chicken (Life Raft) – Listeria contamination (2023)

Guardian System (Angel Medical) – premature service end (2023)

LAVH Pack (American Contract) – component investigation (2023)

Breast Plastics Pack (American Contract) – component investigation (2023)