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
Spacelabs Healthcare recalled 8,179 DVI display cables on September 5, 2025, due to electromagnetic interference issues. The cables can interfere with sensitive medical devices, posing serious safety risks. Patients and healthcare providers must stop using the product immediately.
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Spacelabs Healthcare, Inc. or your healthcare provider for instructions. Notification method: Letter
The recalled product is a 6-foot DVI-I to DVI-I male/male display cable, identified by model number 012-0895-01. The cables were distributed worldwide, including all states in the U.S. and numerous countries.
The cables do not comply with electromagnetic interference standards. They may disrupt the operation of sensitive medical devices, posing serious risks to patient safety.
There have been no reports of injuries or deaths linked to this recall. However, the potential for interference with critical medical equipment raises concerns.
Stop using the recalled DVI display cables immediately. Follow the recall instructions from Spacelabs Healthcare, or consult with your healthcare provider for guidance.
For more information, contact Spacelabs Healthcare, Inc. or visit their recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0167-2026.
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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