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Other Medical Devices

🏥 Medical Devices • 15,809 recalls

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

Invacare

Class I - Dangerous

Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

Jun 15, 2023 Other Medical Devices Nationwide View Details →

Centurion FMS Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

Legion FMS Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S

Olympus Corporation of the Americas

Class I - Dangerous

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

Jun 8, 2023 Other Medical Devices Nationwide View Details →

Constellation Procedure Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

Infinity FMS Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

Alcon Custom Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

Abbott Diabetes Care

Class I - Dangerous

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

Jul 12, 2023 Other Medical Devices Nationwide View Details →

Phaco Standalone Tips

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

Randox Laboratories

Class I - Dangerous

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

Jun 13, 2023 Other Medical Devices Nationwide View Details →

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

Philips North America

Class I - Dangerous

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Jun 12, 2023 Other Medical Devices Nationwide View Details →

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

Philips North America

Class I - Dangerous

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Jun 12, 2023 Other Medical Devices Nationwide View Details →
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