The Recall Desk
HighFDA (Devices)·Z-1848-2012·Announced 2012-06-27

FDA Recalls Covidien Roticalutor Staplers Due to Sterility Barrier Risk

The FDA is recalling specific lots of the Covidien Roticalutor 30-V3 Single Use Stapler because the sterility barrier may be compromised.

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: The recall is classified as FDA Class II, and the hazard involves a potential sterility barrier compromise in a surgical device. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Roticalutor 30-V3 Single Use Stapler, Reference Number 017619. The recall involves 17,848 units of the device, which is used in abdominal, gynecologic, and pediatric surgery for resection, transection, and the creation of anastomosis.

The recall is being conducted because there is a potential for the sterility barrier of the device to be compromised. This defect could affect the sterility of the instrument during use. The affected products were distributed worldwide, including in the United States and numerous international markets.

Specific lot numbers are identified in the recall notice, including those beginning with certain letter and number combinations such as P7E, P8B, and P9H. Certain lot numbers ending in "RMX" and "RRMX" are explicitly stated as not affected and are acceptable for use. Healthcare providers and facilities should check their inventory against the specific lot numbers listed in the official recall documentation to determine if they possess affected units.

The recalled product

Product
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Manufacturer
Covidien LP
Category
Medical Device — Surgical Stapler
Hazard
Affected units
17,848

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)

  • OOZ0976
  • OOZ1401
  • OOZ1407
  • OOB0117
  • P2B0488XR
  • P2B0153XR

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Covidien LP 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 5 products in this recall →

Related recalls

Same manufacturer · Covidien LP

See all →

Same hazard · sterility compromise

See all →