🔍 RecallPedia

All Recalls

95,025 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,578
Consumer Products

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Canon Medical System, USA

🏥 Medical Devices Class I - Dangerous

A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

Nov 11, 2020 Diagnostic Equipment Nationwide View Details →

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Philips Ultrasound

🏥 Medical Devices Class I - Dangerous

Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.

Sep 21, 2021 Diagnostic Equipment View Details →

Tenaculum, Plastic

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →

Atellica IM 1300 Analyzer, SMN 11066001

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

Sep 28, 2021 Other Medical Devices Nationwide View Details →

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.

Medtronic Xomed

🏥 Medical Devices Class I - Dangerous

There was an increase in complaints related to tip breaks and wobble/vibration.

Aug 31, 2021 Other Medical Devices Nationwide View Details →

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601

Instrumentation Laboratory

🏥 Medical Devices Class I - Dangerous

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

Aug 25, 2021 Infusion Pumps Nationwide View Details →

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

Medtronic Xomed

🏥 Medical Devices Class I - Dangerous

There was an increase in complaints related to tip breaks and wobble/vibration.

Aug 31, 2021 Other Medical Devices Nationwide View Details →

Endometrial Biopsy Kit

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →

Standard IUD Insertion Kit

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966

Ortho Clinical Diagnostics

🏥 Medical Devices Class I - Dangerous

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

Sep 10, 2021 Diagnostic Equipment Nationwide View Details →