FDA MedWatch Alerts
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
23 Apr 2026
00:00
Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.
23 Apr 2026
00:00
Early Alert: Convenience Kit Issue from Aligned Medical Solutions
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.
22 Apr 2026
00:00
Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps
Tandem is correcting Mobi insulin pumps operating on affected software versions (7.6.0.1, 7.6.0.3, and 7.7.0.1) which may incorrectly detect a motor issue.
20 Apr 2026
00:00
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack
On April 02, 2026, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of two convenience kits that contain the Medline Namic Angiographic Rotating Adapter(RA) 10CC Syringe. Associated kits are AMS6908E Angio Pack and AMS6908F Angio Pack.
16 Apr 2026
00:00
Early Alert: Convenience Kit Issue from Medical Action Industries
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.
16 Apr 2026
00:00
Early Alert: Convenience Kit Issue from American Contract Systems
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.
15 Apr 2026
00:00
Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve
Percussionaire Corporation issues updated instructions for ventilator tubes due to design defect that could cause hypoventilation, respiratory failure
15 Apr 2026
00:00
Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
Philips Trilogy Evo Ventilators may not function as intended if used with certain nebulizers.
15 Apr 2026
00:00
Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole.
14 Apr 2026
00:00
Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
Draeger corrects the Atlan A350, A350 XL for piston ventilator failures and mechanical ventilation issues due to manufacturing impurities
14 Apr 2026
00:00
Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
The Merit 16F Dual-Valved Splittable Sheath Introducer may not split as intended. This may cause bleeding, embolization, or loss of vessel for future access.
10 Apr 2026
00:00
Early Alert: Convenience Kit Issue from AVID Medical
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.
09 Apr 2026
00:00
Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits
When the Volara system is used in a home setting, there is a risk for oxygen desaturation or barotrauma if it is used in-line with a ventilator.
09 Apr 2026
00:00
Early Alert: Sizing Catheter Issue from Cook Medical
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
08 Apr 2026
00:00
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.
03 Apr 2026
00:00
Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes
Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops.
03 Apr 2026
00:00
Heart Pump Correction: Abiomed Updates Use Instructions for Impella RP with SmartAssist Devices
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.
01 Apr 2026
00:00
Aphreseller (Buy-herbal.com) Issues Voluntary Nationwide Recall of Kian Pee Wan Capsules Due the Presence of Undeclared Dexamethasone and Cyproheptadine
FOR IMMEDIATE RELEASE – 03/30/2026 - Flushing, New York, Aphreseller (Ebay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA analysis has found that the product contains the undeclared drug ingredients dexamethasone and cyproheptadine. Products cont