FDA medical device recalls

Aju Pharm's AlternatiV+ Screw-In Anchor has been recalled due to reports of device failure. The anchor may break, bend, pull out, or the suture may break during use. Approximately 416 units were distributed in California and Puerto Rico.

Aju Pharm's AlternatiV+ Max Knotless Anchor surgical device has been recalled due to reports of failure, including anchor breakage, bending, and pulling out during use. The issue affects all lots of models 20KPN4751 and 20KPN5501 distributed in California and Puerto Rico.

Aju Pharm's Genesis Push-In Suture Anchor has been recalled due to reports of device failure during use, including the anchor breaking, bending, or pulling out, as well as suture breakage. About 200 units were distributed nationwide in California and Puerto Rico.

Aju Pharm Co., Ltd. is recalling Genesis Knotless Anchor surgical devices due to reports of device failure. The anchor can break, bend, pull out of tissue, the suture can break, or the packaging can break during handling or use.

Aju Pharm Co., Ltd. is recalling Genesis Dual Thread Screw-In Anchor devices (Models 10N47502 and 10N55002) due to reports of failure during use. The anchor may break, bend, pull out, or cause the suture to break.

Aju Pharm Co., Ltd. is recalling Genesis Screw-In Anchor devices due to reports of failure, including anchor breakage, bending, pull-out, suture breakage, and packaging damage. The recall affects models 10B45003, 10B55003, and 10B65003 distributed nationwide in California and Puerto Rico.

Aju Pharm's Fixone Biocomposite Anchor has been recalled due to reports of device failure, including anchor breakage, bending, pulling out, suture breakage, and packaging damage. The recall affects 1,088 units distributed in California and Puerto Rico. No injuries have been reported to date.

Aju Pharm's Fixone Hybrid Anchor, a surgical device, has been recalled due to reports of device failure. Problems include the anchor breaking, bending, or pulling out during use, as well as suture breakage and packaging damage. This affects 233 units distributed in California and Puerto Rico.

Cerapedics recalled PearMatrix P-15 Peptide Enhanced Bone Graft (1.0cc) due to an incorrect expiration date on certain units. The affected lot is 7014819. No injuries have been reported.

Elekta medical linear accelerators used in cancer radiation therapy have a manufacturing defect affecting electrical grounding in certain models and lot codes. The issue could potentially affect the safe operation of these systems. No injuries have been reported to date.

The Broselow Tape, a tool used in pediatric emergency care to determine medication doses based on a child's length and weight, contains dosing errors for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to incorrect doses being given in emergency situations. The affected units have specific lot numbers and are distributed in the US, Canada, Hong Kong, and Singapore.

The Broselow Tape, a tool used in pediatric emergency care to determine correct medication doses based on a child's length and weight, contains dosing errors for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to incorrect doses being given during emergency treatment.

SunMed Holdings is recalling certain Broselow Pediatric Emergency Rainbow Tapes because they contain incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong drug doses during pediatric emergency care. This is a serious safety issue affecting emergency departments and medical facilities.

The Broselow Tape, a tool used in pediatric emergencies to calculate medication doses based on a child's length and weight, contains incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong doses being given during emergency care. The FDA has classified this as a Class I recall, the most serious category.

GVS released 2,720 SQ40S blood transfusion filters without completing required quality control testing. Because the sterility verification process was not finished, the company cannot confirm these filters are safe to use. The affected lot number is 7536142.

Philips released a software update (version 4.5.0) for the Patient Information Center iX that changes how mobile event notifications are filtered. The system makes these changes without alerting users, so staff may not realize their notification settings have been altered.

The FDA identified potential cybersecurity issues with Edan's iT20 telemetry transmitter, a device used in hospitals to monitor patient heart rhythm and oxygen levels wirelessly. The company received an FDA notice asking it to address these vulnerabilities. No injuries have been reported.

The FDA identified potential cybersecurity issues with Edan iM8, iM8A, and iM8B patient monitors. These devices are used in medical settings to continuously monitor heart rhythm, blood oxygen, blood pressure, and other vital signs. The vulnerability could potentially allow unauthorized access to the device or its data.

The FDA identified potential cybersecurity issues with certain Edan M3A Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The FDA sent a letter to the manufacturer asking them to address the security vulnerabilities.

The FDA identified potential cybersecurity issues with Edan's M3B Vital Signs Monitor, a hospital device that tracks oxygen levels, heart rate, and CO2. Certain serial numbers manufactured between 2015 and 2024 may be affected. No patient injuries have been reported.

Edan Diagnostics' MFM-CNS and MFM-CNS Lite clinical software systems for fetal and maternal monitoring have potential cybersecurity vulnerabilities. The FDA identified these issues and requested action from the manufacturer. No patient harm has been reported.

Edan Diagnostics' MFM-CMS central monitoring system has potential cybersecurity issues that could allow unauthorized access to patient monitoring data. The FDA issued a notice asking the company to address these vulnerabilities. About 195 units are affected.

The FDA identified potential cybersecurity issues with certain Edan iX series patient monitors (models iX10, iX12, iX15). These devices are used in hospitals and clinics to continuously monitor patients' vital signs. The affected units have specific serial numbers and manufacturing dates.

Edan Diagnostics received an FDA warning letter about potential cybersecurity issues affecting certain X-series patient monitors (models X8, X10, and X12) used in hospitals and clinics. These devices continuously monitor patient vital signs, and security vulnerabilities could potentially allow unauthorized access.

The FDA identified potential cybersecurity issues with Edan's iM20 patient monitor system, which is used in hospitals and during patient transport to track vital signs like heart rhythm, blood pressure, and oxygen levels. The company received an FDA letter about these vulnerabilities. No injuries have been reported.

The FDA identified potential cybersecurity issues in Edan Diagnostics patient monitors (elite V5, V6, and V8 models). These devices are used in hospitals and clinics to continuously monitor patient vital signs like heart rate, blood pressure, and oxygen levels. The company has been notified and is working to address the vulnerabilities.

Edan patient monitors (models iM50, iM60, iM70, and iM80) have potential cybersecurity vulnerabilities that could allow unauthorized access to the device. The FDA identified these issues and is requiring the manufacturer to address them. No injuries have been reported.

Edan Diagnostics recalled certain iM3s series vital signs monitors (models iM3s, iM3As, iM3Bs, iHM3s) due to potential cybersecurity issues identified by the FDA. These monitors measure patient vital signs in clinical settings. The recall affects 136 devices with specific serial numbers distributed across the U.S. and Mexico.

The FDA identified potential cybersecurity issues with Edan's iM3 vital signs monitor, a device used in hospitals and clinics to measure blood pressure, oxygen levels, heart rate, and temperature. The company has been notified and is working to address these vulnerabilities.

The FDA identified potential cybersecurity issues with certain Edan Model M3 Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The company received an FDA notice about the vulnerability.