Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
GE Medical Systems recalled 7,302 AW Server units on September 5, 2025, due to a critical security vulnerability. The flaw could allow unauthorized access to sensitive patient data. Healthcare providers and patients must cease use immediately and follow recall procedures.
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, SCS or your healthcare provider for instructions. Notification method: Letter
The recall involves AW Server models 2.0, 3.0, 3.1, and 3.2. The devices were distributed to healthcare facilities across the United States and internationally. The affected quantity includes 1,381 units in the U.S. and 5,921 units overseas.
A security vulnerability in the AW Server products poses a high risk. If exploited, it could compromise the confidentiality, integrity, and availability of patient data.
No specific incidents or injuries have been reported as a result of this vulnerability. However, the potential for unauthorized access to sensitive data represents a significant risk.
Healthcare providers and patients should stop using the affected devices immediately. Follow the instructions provided in the recall notification from GE Medical Systems.
For further assistance, contact GE Medical Systems at their official website or customer service hotline.
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date