Medical Device Recalls - Market Recalls

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 – Stent delivery system may encounter complications during deployment which may… – INSPIREMD Inc

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software… – Devices were distributed in the U.S. market without obtaining the… – Guangzhou Pluslife Biotech Co., Ltd.

Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card…

Vista Dental Products Sodium Hypochlorite – 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 – The affected lots may be packaged in syringes which include… – Inter-Med Llc

Vista Dental Products Sodium Hypochlorite – 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free…

DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D – Ameditechs Drugs of Abuse Tests listed above have shown reduced… – Ameditech Inc

DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information…

Grandio SO Heavy Flow Caps, Color A3 – Product Usage: Filling minimally invasive cavities of all… – The metal cannula are potentially too loose and may become… – Voco GmbH

Grandio SO Heavy Flow Caps, Color A3 – Product Usage: Filling minimally invasive cavities of all classes – Filling small class I cavities and extended fissure sealing – Filling class II – V cavities including…

GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system… – The SFD/IDD safety mechanism may not engage properly at the… – GE Healthcare

GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone…

Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids… – Confirmed increase in false susceptible and false intermediate misreads for… – Siemens Healthcare Diagnostics, Inc.

Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed…

Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used… – There may be missing notches, partial notches or no notches… – Stryker Instruments Div. of Stryker Corporation

Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose…

FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm)… – Medtronic is recalling a specific subset of lot numbers of… – Medtronic Vascular, Inc.

FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…

Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054 – Products shipped to US locations that do not have approved… – LumiQuick Diagnostics Inc.

Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.