Agency classClass IIOur severity:Severe FDA (Devices)·Z-1845-2012·Announced 2012-06-27

FDA Recalls Covidien Roticalator Staplers Due to Sterility Barrier Risk

The FDA is recalling 13,531 units of the Covidien ROTICULATOR 55-4.8 Single Use Stapler because the sterility barrier may be compromised.

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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source does not explicitly mention hospitalizations, the potential for sterility compromise in a surgical device represents a significant risk of harm, aligning with the Severe classification for high-risk medical devices.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 13,531 units of the Covidien ROTICULATOR 55-4.8 Single Use Stapler (REF# 017614). The recall is due to a potential for the sterility barrier to be compromised, which could affect the safety of the device during use.

The affected staplers are used in abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomosis. The recall covers specific lot numbers beginning with designated letter/number combinations, as well as certain Best Practice Kits. Specific lot numbers ending in "RMX" and "RRMX" are not affected and remain acceptable for use.

The product was distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and users should stop using the affected units and contact the recalling firm, Covidien LP, for further instructions.

The recalled product

Product: Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 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: sterility-compromise
infection
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 →

Same manufacturer · Covidien LP

See all →

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High
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High
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Same hazard · sterility compromise