MedWatch Safety Alerts

Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical Procedures

Ethicon Endo-Surgery is correcting the Endopath Echelon due to a potential surgical lockout that stops cutting or stapling and requires extra removal steps

Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure

Edwards recalls arterial cannulae due to risk of wire exposure that may cause serious patient harm

Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment

Baxter is removing mobile lift components due to risk of false attachment, which may result in patient injury due to falls

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used

Early Alert: Infusion Pump Issue from Baxter

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries

Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns

MicroMyst Applicators are being recalled due to potential non-sterile product., but these devices may not have been properly sterilized

Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients

Maquet is updating Servo Ventilator instructions due to a risk of inaccurate tidal volume delivery when the extended leak test is used

Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being Used

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used

Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels

Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death

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

Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers

The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns

Early Alert: Infusion Set Performance Issue from BD

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and

Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape

Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation

AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature