Medisafe Distal Duck Kit (Steris) – Bacterial Contamination (2020)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
Brand
Steris Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Steris Corporation is recalling Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: inte due to STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 11/23/2020, STERIS issued Urgent Device Correction notices to customers via courier service. Instructing customers to inspect and destroy any remaining affected products in their inventory. STERIS will provide replacement product at no cost to Customers who have product remaining in stock.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026