2,143 recalls tagged with “cpsc regulated”.
Medline recalled 4.4 million Quick Strip Plastic Sterile Adhesive Bandages on October 27, 2025. The recall affects all lots due to potential open seals compromising sterility. Consumers and healthcare providers should stop using these bandages immediately.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
EDAN recalled 377 iM20 Patient Monitors on October 24, 2025, due to cybersecurity issues. The recall affects devices distributed nationwide in the U.S. and Mexico. Healthcare providers must stop using this device immediately.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.
EDAN recalled 379 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models iX10, iX12, and iX15 pose risks to patient safety. Healthcare providers should stop using these devices immediately.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Potential contamination of Salmonella Richmond
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
EDAN recalled 11,987 iM3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity risks. The recall affects devices distributed across the United States and Mexico.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.
EDAN recalled 342 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models affected include elite V5, elite V6, and elite V8. Healthcare providers and patients should stop using these devices immediately.