The Recall Desk
HighFDA (Devices)·Z-1482-2022·Announced 2022-08-10

PRESTIGE RETRACTION GRASPER recalled due to potential weld separation

The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.

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 recall of a surgical instrument with a structural defect (weld separation) that could cause device malfunction during use. However, no patient illnesses, injuries, or adverse events are reported in the recall documentation, placing this at the High severity level per rubric criteria for risk-of-harm products without reported injury.

Plain-English summary

The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument (Product Code 8361-10), manufactured by Aesculap Implant Systems LLC. This device is a dual-action endoscopic retraction grasper used in surgical procedures.

The recall is being issued because the endoscopic graspers may become separated at the weld where the handle connects to the shaft. This defect could result in device malfunction or failure during surgical use.

The affected product was distributed nationwide throughout the United States, including all 50 states, Washington DC, and Puerto Rico. The affected lot numbers are M45171, M46651, M47463, M48124, and M49436. Products can be identified by the UDI-DI: 04046955083381.

Affected healthcare institutions and practitioners should verify whether they have units from the affected lots and should contact Aesculap Implant Systems LLC or the FDA with questions about the recall.

The recalled product

Product
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
399

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 (6)

  • UDI-DI: 04046955083381
  • lots M45171
  • M46651
  • M47463
  • M48124
  • M49436.

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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