Food & drugs

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Provider

19-11-2019

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.

Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material

18-11-2019

Select varieties of Breakstone’s Cottage Cheese are voluntarily being recalled due to the potential presence of pieces of red plastic and metal that may have been introduced during production.

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Ma

18-11-2019

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules...

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk

18-11-2019

Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella.

Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks

18-11-2019

The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration...

Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop

18-11-2019

The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death.

Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

18-11-2019

Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.

2019 Medical Device Recalls

15-11-2019

The list below contains recalls that were issued in 2019.

Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop

15-11-2019

The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death.

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk

15-11-2019

Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella.

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Ma

15-11-2019

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules...

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibit

14-11-2019

Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the...

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Provider

Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Ma

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk

Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks

Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop

Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

2019 Medical Device Recalls

Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Ma

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibit

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

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