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CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands

CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands Recalls

All product recalls associated with CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands.

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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 6001–6020 of 25000 recalls

EP-TRACER Software (CardioTek) – electrical safety (2022)

Device did not pass electrical safety testing for adequate insulation.

FDAApr 25, 2022Nationwide• CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands

Norepinephrine Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Zonisamide Capsules 50mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDA

1...299 300301302 303...1250

Page 301 of 1250Next

Apr 25, 2022

Nationwide

• Glenmark Pharmaceuticals Inc., USA

Fentanyl/Bupivacaine Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Vancomycin HCl Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Zonisamide Capsules 100mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAApr 25, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Zonisamide Capsules 25mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAApr 25, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

EVIS EXERA II Videoscope (Olympus) – part replacement error (2022)

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

FDAApr 22, 2022Nationwide• Olympus Corporation of the Americas

Colonovideoscope (Olympus) – camera unit mismatch (2022)

A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding

FDAApr 22, 2022Nationwide• Olympus Corporation of the Americas

INTERTAN Nail (Smith & Nephew) – left-right labeling error (2022)

Right nails were anodized, marked, and labelled as left nails and vice versa

FDAApr 22, 2022Nationwide• Smith & Nephew Orthopaedics GmbH Alemannenstr. 14 Tuttlingen Germany

ProudP Uroflow Tracker (Dain Technology) – sound processing issue (2022)

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

FDAApr 21, 2022Nationwide• Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)

Atrium Thoracic Catheter (Atrium) – expiration date mismatch (2022)

Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date

FDAApr 21, 2022AZ, IL, KS +7 more• Atrium Medical Corporation

Rebel Pistachio Ice Cream (Rebel Creamery) – nut shell risk (2022)

Pistachio ice cream may contain pistachio nut shells.

Class IIModerate

FDAApr 21, 2022AZ, CA, FL +14 more• Rebel Creamery