FDA Adds StealthStation to Medical Device Recall Page


The following are recent recall updates posted by the US FDA.

The following are recent recall updates posted by the US Food and Drug Administration:

FDA Updates 2019 Medtronic Recall of StealthStation

Date Initiated by Firm: August 9, 2019

Medtronic recalled the auto-registration feature of its StealthStation DBS Software in August, 2019, due to inaccuracies caused by patient movement during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system.

This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures. This could result in serious or life-threatening patient harm.

As of June 2020, a total of 33 medical device reports were identified: 22 related to device malfunction and 11 related to injuries.

Read the recall statement.

Lupin Pharmaceuticals, Inc. Terminates Recall of Metformin Hydrochloride Extended-Release Tablets

FDA Publish Date: June 11, 2020

The recall of Metformin Hydrochloride Extended-Release Tablets USP, 500mg has been officially terminated.

The product is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

Read the recall statement.

NOW Health Group Inc. Recalls Macadamia Nuts Because of Possible Salmonella Contamination

FDA Publish Date: June 12, 2020

NOW Health Group, Inc. recalling its “Real Food Raw Macadamia Nuts” — Product Code 7119, Lot # 3141055.

The specific lot has the potential to be contaminated with Salmonella. In very rare cases (5% or fewer), Salmonella can become a bloodstream infection, leading to severe illness.

Read the recall statement.

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