Medisafe Distal Duck Kit and Duck Bag — Class II medical device recall Z-0830-2021
Terminated recall by Steris Corporation, reported 2021-01-20, distributed nationwide. STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluor
| Recall number | Z-0830-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CN, DE, DK, GB, GR, IE, JP, KR, NO, PL, PT, QA, RO, SA, SE, TH |
| Reason classes | microbial contamination |
| Pathogens | pseudomonas |
| Lot numbers | 1811273, 1811277, 1811278, 1901340, 1901349, 1902374, 1903408, 1904448, 1904464, 1905505, 1906484, 1906499, 1906508, 1906529, 1907556, 1907571, 1908593, 1908595, 1909624, 1909635, 1909644, 1910649, 1910651, 1910653, 1911658, 1911680, 1911691, 1912700, 1912708, 2001717, 2001718, 2001719, 2001730, 2004766, 2004768, 2004770, 2004772, 2004774, 2006797 |
| Model numbers | M20350, M20358, M20359, M20400 |
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.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0830-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.