RecallRadar

FDA Device recall Z-1481-2022

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

On 2022-08-10 the FDA classified a Class II recall of PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10 by Aesculap Implant Systems, citing endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1481-2022
ClassificationClass II
Statuscompleted
Initiated2020-04-01
Published2022-08-10
Last updated2026-09-13 11:56 UTC
CompanyAesculap Implant Systems
DistributionUS

Product

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

Reason

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Identifiers

code_info
UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M4…UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1481-2022%22

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