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Other Medical Devices

🏥 Medical Devices • 15,203 recalls

Foundation Kit

Stradis Medical, LLC

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 →

IUD Insertion Pack

Stradis Medical, LLC

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 →

6.5MMX165MM CANNULATED SCREW

Smith & Nephew

Class I - Dangerous

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Sep 20, 2021 Other Medical Devices Nationwide View Details →

IUD Insertion Kit

Stradis Medical, LLC

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 1600 Analyzer, SMN 11066000

Siemens Healthcare Diagnostics

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 →

Tenaculum, Plastic

Stradis Medical, LLC

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

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

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 →

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

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

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

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 →

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 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

Medtronic Xomed

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 →
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