The Recall Desk
ModerateFDA (Devices)·Z-1636-2013·Announced 2013-07-10

Surgical Instrument Service And Savings Recalls Suture Graspers Due to Seal Compromise

Surgical Instrument Service And Savings, Inc. is recalling two lots of IDEAL Suture Graspers because the sterile barrier seal may be compromised, allowing the product to fall out of the pouch.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier seal, which is a significant quality defect but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity score.

Plain-English summary

Surgical Instrument Service And Savings, Inc. is recalling two specific lots of IDEAL Suture Graspers. The affected products are the IDEAL 30 Suture Grasper (Green) 30 Degree (Reference 251721, Lot 122511) and the IDEAL 60 Suture Grasper (Pink) 60 Degree (Reference 251723, Lot 122631). These items were distributed nationwide.

The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising the sterile status of the instrument.

Healthcare providers and facilities that have received these specific lots should stop using them and contact the recalling firm for instructions on return or replacement. Consumers should not use these medical devices if they possess them.

The recalled product

Product
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
Affected units
2

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 (2)

  • 122511
  • 122631.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. 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 22 products in this recall →