Recall

All recalls7,819 total

D
Dr. Reddy's Laboratories, Inc. — Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

O
O
O
O
M
Medline Industries, LP — DEXLOCK Achilles Repair Implant Kits, MAKT4520

There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

A
O
O
O
O
O
O
A
A
W
Waldemar Link GmbH & Co. KG (Mfg Site) — Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement device

The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

B
R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufac

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

B
Beckman Coulter, Inc. — Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Nu

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufac

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

I
Intuitive Surgical, Inc. — Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Produ

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manu

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufac

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fe

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

R
Rocket Medical Plc — Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manu

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

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