The Recall Desk
HighFDA (Devices)·Z-1847-2012·Announced 2012-06-27

FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 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, which poses a risk of harm without reported injuries or fatalities.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien ROTICULATOR 30-4.8 Single Use Stapler (REF# 017617). The recall involves 28,248 units that were distributed worldwide, including in the United States and numerous international markets. The product is used in abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomosis.

The reason for the recall is the potential for the sterility barrier to be compromised. This defect could affect the sterility of the surgical instrument. Specific lot numbers are identified in the recall notice, with certain combinations beginning with letters and numbers such as P7E, P8B, and P8L. The notice explicitly states that lot numbers ending in "RMX" and "RRMX" are not affected and remain acceptable for use.

Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the recalled staplers. Consumers are not directly affected as this is a professional medical device, but patients who have had surgery using these specific devices should consult their healthcare provider if they have concerns.

The recalled product

Product
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 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
28,248

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 →