Agency classClass IIOur severity:Severe FDA (Devices)·Z-1844-2012·Announced 2012-06-27

FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

The FDA is recalling specific lots of Covidien ROTICULATOR 55-3.5 Single Use Staplers because the sterility barrier may be compromised, posing a risk of infection during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 infection from a compromised sterility barrier 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 55-3.5 Single Use Stapler (REF# 017612). The recall is due to a potential for the sterility barrier to be compromised, which could result in the device not being sterile when used.

The affected product is used in abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomosis. The recall covers 50,698 units 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 providers and facilities should stop using the affected lots immediately 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 potential infection.

The recalled product

Product: Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 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: infection
sterility-compromise
Affected units: 50,698

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 →

Same manufacturer · Covidien LP

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Same hazard · infection