Maquet
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Maquet and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-22FDA-DeviceClass IIMaquet Vasoview Hemopro 2 recalled for sterilization failure
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
- 2026-02-11FDA-DeviceClass IICheck Maquet bubble sensor cable connections
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
- 2013-10-09FDA-DeviceClass IIContact Maquet about Ultima OPCAB blade mislabeling
MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
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