FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

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

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

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

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

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

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

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

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

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

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.

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 that may have been serviced with previously recalled bezel kit assemblies.

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

Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.

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.

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

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

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 terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

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

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