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Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden

Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden Recalls

All product recalls associated with Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden.

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Recall Summary

Total Recalls

1000

Past Year

206

Class I (Serious)

410

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 281–300 of 3552 recalls

Hybrid Recon Software (Hermes Medical) – reconstruction alignment risk (2024)

Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

Moderate

FDAOct 31, 2024CA, CT, FL +12 more• Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden

Tempus LS-Manual Defibrillator (Remote Diagnostic) – incorrect labeling (2024)

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Low

FDAOct 28, 2024Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Proteus XR/A Radiographic System (GE Healthcare) – wall stand cable risk (2024)

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

1...13 141516 17...178

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Moderate

FDAOct 24, 2024Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

Smaxel CO2 Laser (IDS) – Certification Labeling Issue (2024)

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Low

FDAOct 16, 2024Nationwide• IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)

Vue PACS Viewer (Philips) – Calculation Errors (2024)

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

High

FDAOct 10, 2024Nationwide• Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel

BBQ Pulled Chicken Sandwich (Whitsons) – Listeria contamination (2024)

Listeria

Product may be contaminated with Listeria monocytogenes.

Class IIModerate

FDAOct 10, 2024NY• Whitsons Food Service (Bronx), LLC

Philips Zenition 70 (PHILIPS) – Mains Control Unit Fuse Issue (2024)

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

High

FDAOct 7, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Philips Zenition 50 (PHILIPS) – Mains Control Unit Fuse Issue (2024)

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

High

FDAOct 7, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Bard Marquee Biopsy Instrument Kit (Bard) – Needle Retention Defect (2024)

Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

Moderate

FDASep 30, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Fitbone Trochanteric Nail (Orthofix) – Potential Bending (2024)

Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

Low

FDASep 24, 2024Nationwide• Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy

A1CNow+ HbA1c System (PTS Diagnostics) – Code Mismatch Problem (2024)

The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.

Moderate

FDASep 18, 2024Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Vail-Bon Jie Yang Wan Capsules (123Herbals) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

Class IHigh

FDASep 18, 2024Nationwide• 123Herbals

GOETAS Pool Drain Covers – Entrapment Safety Issue (2024)

This recall involves GOETAS-branded drain covers that are sold for use in swimming pools. The white, plastic, main pool drain covers measure about 7 inches high and have top grates that measure about 9 inches in diameter.

High

CPSCSep 12, 2024Nationwide• GuangZhouShiYiYangKangTiSheBeiYouXianGongSi, dba GOETAS, of China

LINK Universal Handle (Waldemar Link) – Material Failure Risk (2024)

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

High

FDASep 11, 2024Nationwide• Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany

Enterprise Imaging XERO Viewer (Agfa) – Image Placement Bug (2024)

Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.

Moderate

FDASep 6, 2024Nationwide• Agfa Healthcare NV Septestraat 27 Mortsel Belgium

SONIALVISION G4 (Shimadzu) – Image Display Problem (2024)

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Leica Biosystems Cryostat (Leica) – Flammable Spray Risk (2024)

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

High

FDASep 4, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

EVSRF Catheter (Bard) – Wiring Error Risk (2024)

The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.

High

FDASep 4, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438