Agency classClass IIOur severity:High FDA (Devices)·Z-1387-2023·Announced 2023-04-19

Step Bladeless Trocars recalled for sterilization failure

Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

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 3/5 (High).

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: FDA Class II recall with no reported illnesses or injuries. However, unsterile surgical instruments pose a serious potential hazard including infection risk and potential vision loss in ophthalmic applications, meeting the criterion for high-severity risk-of-harm where injury has not been reported.

Plain-English summary

Covidien, LP is recalling 770 units of Step Bladeless Trocars, Model S101010 (Lot P2G0069). The instruments were distributed worldwide following a sterilization process failure.

A supplier calibration issue during contract sterilization may have resulted in unsterile product. Use of unsterile surgical instruments could lead to infection. In ophthalmic applications, there is also a potential risk of vision loss.

The affected units were distributed to multiple U.S. states including Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio, and Washington, as well as internationally to Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.

The recalled product

Product: Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Instruments
Hazard: sterilization-failure
infection-risk
vision-loss
Affected units: 770

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 (2)

GTIN: 10884521090767
Lot: P2G0069

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Covidien, LP

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