The Recall Desk
HighFDA (Devices)·Z-1481-2022·Announced 2022-08-10

Endoscopic Grasper Instruments Recalled Due to Weld Separation Risk

Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device recall with a genuine mechanical hazard—weld separation during surgical use—that poses a clear risk of harm. No reported injuries or hospitalizations are documented in the source, placing this within the High category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aesculap Implant Systems LLC is recalling 3,392 PRESTIGE ATRAUMATIC GRASPER endoscopic surgical instruments with Product Code 8360-10 due to a mechanical defect.

The weld connecting the handle to the shaft of the device may become separated during use, potentially compromising the instrument's functionality during minimally invasive surgical procedures. The affected units span 22 lot numbers: M45041, M45399, M45711, M46069, M46350, M47462, M47893, M48115, M48279, M48346, M48467, M48596, M48753, M48848, M48907, M49375, M49435, M49632, M49683, M49711, M49867, and M55796.

The recalled instruments were distributed nationwide across all U.S. states, the District of Columbia, and Puerto Rico. Healthcare facilities and individuals with these devices should discontinue use immediately and contact Aesculap Implant Systems LLC for instructions on replacement or return.

The recalled product

Product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Surgical Instrument / Endoscopy
Hazard
Affected units
3,392

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 04046955083374
  • lots M45041
  • M45399
  • M45711
  • M46069
  • M46350
  • M47462
  • M47893
  • M48115
  • M48279
  • M48346
  • M48467
  • M48596
  • M48753
  • M48848
  • M48907
  • M49375
  • M49435
  • M49632
  • M49683

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Aesculap Implant Systems LLC

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Same hazard · weld separation

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