The Recall Desk
SevereFDA (Devices)·Z-1846-2012·Announced 2012-06-27

FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

The FDA is recalling specific lots of Covidien ROTICULATOR 30-3.5 Single Use Staplers because the sterility barrier may be compromised, potentially affecting surgical safety.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility compromise in a surgical device.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of the Covidien ROTICULATOR 30-3.5 Single Use Stapler (REF# 017615). The recall is due to a potential for the sterility barrier to be compromised, which could affect the sterility of the device.

The affected product is used in abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomosis. The recall covers 13,531 units that were distributed worldwide, including the United States and numerous international markets. Specific lot numbers are identified in the recall notice, with certain lots ending in "RMX" and "RRMX" explicitly noted as not affected and acceptable for use.

Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement. Patients who have had surgery using these specific devices should consult their healthcare provider if they have concerns about the recall.

The recalled product

Product
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 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
13,531

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 →