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Showing 5721–5740 of 8393 results

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TMJ Reconstruction Prosthesis (Stryker) – Regulatory Approval (2022)

Device was shipped without having regulatory approval.

FDADec 6, 2022IN, MA• Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany

STAT-IntraOp Immunoassay Kit (Future Diagnostics) – High Variability (2022)

Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

FDADec 6, 2022AZ, CA, CO +4 more• Future Diagnostics Solutions B.V. Nieuweweg 279 Wijchen Netherlands

Oncentra Brachy Software (Elekta) – Reconstruction Error (2022)

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Moderate

FDADec 5, 2022Nationwide• Elekta, Inc.

Pick-A-Dent (Young Dental) – Mislabeled Product (2022)

mislabeled product

FDADec 5, 2022Nationwide• Young Dental Manufacturing I, LLC

Surgical Container (Turbett Surgical) – Weld Failure (2022)

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

FDADec 5, 2022Nationwide• Turbett Surgical, Inc.

Enterprise Imaging XERO Viewer (Agfa) – Software Defect (2022)

There is a software defect that can cause issues with images.

FDADec 5, 2022Nationwide• Agfa Healthcare NV Septestraat 27 Mortsel Belgium

Vanta Clinician Programmer (Medtronic) – Software Anomalies (2022)

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

FDADec 3, 2022Nationwide• Medtronic Neuromodulation

Nylon Suture (McKesson) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Surgidac Polyester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Lamaze Chill Teether (Tomy) – Microbial Growth Risk (2022)

Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.

FDADec 2, 2022Nationwide• Tomy International Inc.

Custom Suture Pack (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Surgipro Polypropylene Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Dermalon Nylon Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Surgilon Nylon Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Codman Surgical Patties (Integra) – Endotoxin Issue (2022)

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

FDADec 2, 2022Nationwide• Integra LifeSciences Corp.

Monosof Nylon Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Sofsilk Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Novafil Polybutester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Medical Cutting Needle (Remington) – Incorrect Stylet Length (2022)

The stylet is longer than specified on the label

FDADec 2, 2022AL, CA, NC +3 more• Remington Medical, Inc.

Surgipro II Polypropylene Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

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