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Food & drugs

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

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

 The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...

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Three Michigan Men Indicted for Distribution of THC Vape Cartridges

07-07-2020

FDA OCI, distribution, THC, vape, cartridges, indicted, Artyom Garber, Paul Queenan, John Botsford, Michigan, seizure, Dearborn Heights MI, Ann Arbor...

Food & drugs

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

07-07-2020

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the...

Food & drugs

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750

06-07-2020

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750...

Food & drugs

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential

06-07-2020

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer...

Food & drugs

UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

06-07-2020

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.

Food & drugs

False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care

06-07-2020

FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.

Food & drugs

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

03-07-2020

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems,...

Food & drugs

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750

03-07-2020

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750...

Food & drugs

The J. M. Smucker Company Issues Voluntary Recall of One Lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula Can

03-07-2020

The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat...

Food & drugs

2020 Medical Device Recalls

02-07-2020

List of Medical Device recalls in 2020.

Food & drugs

Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wire

02-07-2020

Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.

Food & drugs

Jewel-Osco Voluntarily Recalls Bagged Signature Farms Garden Salad Due to Possible Cyclospora Contamination

02-07-2020

In cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections in the Midwest, Jewel-Osco...