logo

FDA MedWatch Alerts

15 May 2026
00:00

Early Alert: Anesthesia Machine Issue from Draeger, Inc.

Draeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.
13 May 2026
00:00

Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles

FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials i
12 May 2026
00:00

Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
12 May 2026
00:00

Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination

- May/8/2026- Jackson, WI, Pharmacal is recalling one lot of MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube to the consumer level. The product has been found to be contaminated with Staphylococcus aureus.
11 May 2026
00:00

Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
07 May 2026
00:00

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
07 May 2026
00:00

Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
07 May 2026
00:00

Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps

Brady SMR6 is now available for ACCOLADE pacemakers and CRT-Ps; correction expanded to include CRT-P and DR-EL devices.
07 May 2026
00:00

Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing Namic RA Syringes

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
06 May 2026
00:00

Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers

The FDA issued a LHCP to notify providers that Neurosurgical Patties, Sponges, and Strips (product code HBA) are experiencing a supply disruption.
05 May 2026
00:00

Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters

When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
05 May 2026
00:00

Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads

Certain SureForm Surgical Stapler reloads may form incomplete staple lines, leading to severe bleeding or death.
05 May 2026
00:00

Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems

FT. LAUDERDALE, FL – May 1, 2026 – Trividia Health, Inc., a global leader in diabetes management, today provided an important update to the medical device labeling correction it announced on February 6, 2026, for all TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO Blood Glucose
30 Apr 2026
00:00

Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods

Omnipod Pods may not deliver insulin as intended due to a tear in the internal tubing.
28 Apr 2026
00:00

Early Alert: Thoracic Stent Graft Issue from Bolton Medical

Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death
28 Apr 2026
00:00

Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication

FDA alerts of risks with use TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health.
28 Apr 2026
00:00

B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution

For Immediate Release - BETHLEHEM, PA – APRIL 28, 2026 – B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution.
28 Apr 2026
00:00

Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems

Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately.
24 Apr 2026
00:00

Early Alert: Automated Compounding System Issue from Omnicell

Certain labels used with i.V.Station automated compounding systems may not be detected, leading to mislabeled sterile filled syringes
24 Apr 2026
00:00

Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers