Use caution Medical device recall · FDA · Published March 1, 2023

Covidien Step Bladeless Trocars Recall: Unsterile Risk of Infection or Vision Loss

Covidien recalls Step Bladeless Trocars with possible unsterile product due to supplier calibration issues. Use may cause infection or vision loss in eye sutures. Affected units include specific product numbers and lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1387-2023Medical device Covidien ›

Use caution until it’s fixed

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

Take action

Contact the company

Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

Covidien is recalling Step Bladeless Trocars that may not be properly sterilized during manufacturing, which could lead to infections or vision loss if used in eye procedures. This recall affects specific product models and lots sold to medical facilities. Read more at govinfonow.com/recall/58807-covidien-step-bladeless-trocars-recall-unsterile-risk-of-infection-or.

Source Summary by GovInfoNow · govinfonow.com/recall/58807-covidien-step-bladeless-trocars-recall-unsterile-risk-of-infection-or · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1387-2023

Cite this page

“Covidien Step Bladeless Trocars Recall: Unsterile Risk of Infection or Vision Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58807-covidien-step-bladeless-trocars-recall-unsterile-risk-of-infection-or. Based on FDA recall #Z-1387-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1387-2023%22&limit=1).

The FDA announced on March 1, 2023, that Covidien, LP is recalling Step Bladeless Trocars due to a supplier calibration issue during contract sterilization that may result in unsterile product. Use of the affected devices could lead to unspecified infection or loss of vision if used in eye surgery.

How to tell if you have it

Brand: Covidien
Product: Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer
Product Number: S101010
UPC: 10884521090767
Lot Code: P2G0069

The hazard

Medtronic identified a supplier calibration issue during the contract sterilization process that may lead to unsterile product. The record states that use of the affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

Context

GovInfoNow's records show Covidien, LP has had 26 other recalls on record since July 17, 2017. Recent similar product recalls include the Covidien Mon-a-Therm Stethoscope Recall (April 23, 2026) and the Argon Medical Devices One-Piece Introducer Tray Recall (June 1, 2026).

How to tell if you have this one

Check for product number S101010, GTIN 10884521090767, and lot number P2G0069 on the device packaging. These items were sold to medical facilities starting from the date of manufacture.

Brand
Covidien
Product
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.

Recall number	Product, codes & lots	Quantity
Z-1387-2023	Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010; GTIN: 10884521090767; Lot: P2G0069	770 units
Z-1388-2023	Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203); GTIN: 20884521054001, 20884521054056, 20884521054889, 20884521054896, 20884521054896, 20884521054902, 20884521054902, 10884521054905, 20884521054940, 20884521055688, 20884521055770, 20884521056135, 10884521056145, 20884521056142, 20884521056142, 20884521056142; Lot: D2H1593ZY D2H1022ZY D2F1106ZY D2H1607ZY D2H1609ZY D2H0819ZY D2H2053ZY D2H2053ZY D2H2055ZY D2H1435FZY D2H0829FZY D2H0830FZY D2H0381ZY D2H1523ZY D2H1584ZY D2H1584ZY D2H1587ZY D2H1589ZY	36204 units
Z-1389-2023	Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K); GTIN: 20884521054339, 20884521054438; Lot: D2H0095ZY, D2H0096ZY	960 units
Z-1390-2023	Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2); GTIN: 20884521055756, 20884521750118; Lot: D2G1825FZY, D2H0754FZY, D2E2595ZY	3228 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product number S101010, GTIN 10884521090767, and lot number P2G0069 on the device packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

FDA distribution: “Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Puerto Rico, Washington.

Recall timeline

FDA published this recall 49 days after the firm started it.

Mar 1, 2023Firm started the recall
Apr 12, 2023FDA classified it Class II
Apr 19, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall indicates a potential for infection or vision loss with eye sutures, but no specific injury mechanism is described for general use.

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Link to this recall

<a href="https://govinfonow.com/recall/58807-covidien-step-bladeless-trocars-recall-unsterile-risk-of-infection-or">Covidien Step Bladeless Trocars Recall: Unsterile Risk of Infection or Vision Loss (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1387-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1387-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.