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

Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investig

The FDA is reminding owners and operators about repair and maintenance of tanning beds and booths. Owners and operators of tanning beds and booths should perform maintenance recommended by product manufacturers to reduce risk of smoke and fire.

LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.

InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the

Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been c

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b

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

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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