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GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.

GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no. Recalls

All product recalls associated with GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no..

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Recall Summary

Total Recalls

1000

Past Year

1000

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 3401–3420 of 21320 recalls

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.

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

2008T Hemodialysis System w/Bibag (Fresenius) – PCBA leaching risk (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDA

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Sep 6, 2023

Nationwide

• Fresenius Medical Care Holdings, Inc.

2008T HD SYS. W/O CDX Bluestar (Fresenius) – PCBA leaching risk (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

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

2008T HD SYS. CDX w/Bibag Bluestar (Fresenius) – PCBA leaching risk (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

2008T Hemodialysis System without CDX (Fresenius) – PCBA leaching risk (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Portex Pro-Vent Arterial Blood Sampling Kit (Smiths Medical) – component missing (2023)

The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.

Moderate

FDASep 6, 2023Nationwide• Smiths Medical ASD Inc.

Zimmer Dermatome Blades (Zimmer Surgical) – skin graft quality issue (2023)

Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area

Moderate

FDASep 5, 2023Nationwide• Zimmer Surgical Inc

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.

Ethos Collar Stem 100MM (Onkos Surgical) – Tyvek seal breach (2023)

Potential for breach of Tyvek seals.

Low

FDASep 1, 2023AZ, FL, GA +16 more• Onkos Surgical, Inc.

CVS PCSU SJH Pack (American Contract) – component investigation (2023)

Moderate

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