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RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden Recalls

All product recalls associated with RAYSEARCH LABORATORIES AB Eugeniavagen 18c 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 521–540 of 3552 recalls

RayCare Software (RaySearch) – Allergy Warning Issue (2023)

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

High

FDAJul 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

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High

FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

Moderate

FDAJun 30, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

UroLift Visual Obturator (Scholly Fiberoptic) – Weld Defect (2023)

There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

High

FDAJun 23, 2023Nationwide• Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany

ProPlan CMF Guide (Materialise) – Incorrect Guide Versions (2023)

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Moderate

FDAJun 19, 2023Nationwide• Materialise N.V. Technologielaan 15 Heverlee Belgium

Allura Xper X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

Moderate

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

Moderate

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Sterile Ultrasound Gel (Turkuaz) – Sterility Concern (2023)

Sterility of Ultrasound gel can not be guaranteed.

Moderate

FDAJun 9, 2023IL• Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey

BeamAdjust Software (PTW-FREIBURG) – Calibration File Error (2023)

Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.

Low

FDAJun 7, 2023Nationwide• PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany