Lower risk Medical device recall · FDA · Published November 19, 2020

Steris Medisafe Duck Kit Recall: Bacteria Risk in Detergent

Steris recalls Medisafe Distal Duck Kit and Duck Bag detergent lots with possible Pseudomonas bacteria. Darkening color indicates risk; no patient harm reported. Consumers should check model/lot numbers.

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

🇺🇸 FDA recall #Z-0830-2021Medical device Steris ›

Lower-risk recall

STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.

Take action

Contact the company

Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834

✎ GovInfoNow plain-language explainer

Steris is recalling specific lots of Medisafe Distal Duck Kit and Duck Bag detergent due to potential bacterial contamination. The bacteria may cause detergent color to darken over time, but there is no risk to patients and the risk to users is described as improbable. Read more at govinfonow.com/recall/63833-steris-medisafe-duck-kit-recall-bacteria-risk-in-detergent.

Source Summary by GovInfoNow · govinfonow.com/recall/63833-steris-medisafe-duck-kit-recall-bacteria-risk-in-detergent · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0830-2021

Cite this page

“Steris Medisafe Duck Kit Recall: Bacteria Risk in Detergent.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63833-steris-medisafe-duck-kit-recall-bacteria-risk-in-detergent. Based on FDA recall #Z-0830-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0830-2021%22&limit=1).

The FDA announced on 2020-11-19 that Steris Corporation is recalling Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument due to a risk of bacterial contamination. GovInfoNow's records show the recall was initiated voluntarily by the firm.

How to tell if you have it

Brand: Steris
Product: Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument
Model# M20350 Lot# 1811273,1811277,1906484,1908593,1909635,1910651, 1911658,2001730,2004770
Model# M20358 Lot# 1903408,1906508,1907556,1909644,2001718,2004772
Model# M20359 Lot# 1811278,1906499,1910649,1911680,1911691,1912708, 2001719,2004768
Model# M20400 Lot# 1901340,1901349,1902374,1904448,1904464,1905505, 1906529,1907571,1908595,1909624,1910653,1912700, 2001717,2004766,2004774,2006797

The hazard

The FDA said certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. GovInfoNow's records show there is an improbable risk to users from exposure to this bacteria, and no risk to patients.

Context

GovInfoNow's records show Steris Corporation has 31 other recalls on record since 2017-06-15. Recent Steris recalls include a software issue for the HexaVue Focus Integration System (2026-09-23) and a challenge pack recall (2026-08-31). Other recent recalls of similar products include Medline Centurion Shave Kits Recall: Non-sterile Alcohol Prep Pads Risk Infection (2026-03-16), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (2026-06-12), and Medline Convenience Kits Recall: Fungal Contamination Risk (2026-08-11).

How to tell if you have this one

Check for model numbers M20350, M20358, M20359, or M20400 with specific lot numbers listed in the recall notice. The product is used to keep medical instruments moist during transportation.

Brand
Steris
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify your model number and lot number to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark, Ireland, United Arab Emirates, South Korea,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, Delaware, Florida, Iowa, Massachusetts, Ohio, Pennsylvania, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Nov 19, 2020Firm started the recall
Jan 11, 2021FDA classified it Class II
Jan 20, 2021Published in FDA’s Enforcement Report
Oct 25, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/63833-steris-medisafe-duck-kit-recall-bacteria-risk-in-detergent">Steris Medisafe Duck Kit Recall: Bacteria Risk in Detergent (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-0830-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0830-2021 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.