Device recall: First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
FDA enforcement event 79826 is a device recall by an individual recalling firm (name withheld) of Branford, CT, initiated 21 Mar 2018 and classified Class II, with 6 product records.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 9 Apr 2019. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Branford, CT. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica."
Distribution
"The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1895-2018 | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3 | 115 cases/11500 kits | Class II | Terminated | 30 May 2018 |
| Z-1896-2018 | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4 | 1422 cases/99540 kits | Class II | Terminated | 30 May 2018 |
| Z-1897-2018 | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B | 3 cases/210 kits | Class II | Terminated | 30 May 2018 |
| Z-1898-2018 | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6 | 359 cases/10770 kits | Class II | Terminated | 30 May 2018 |
| Z-1899-2018 | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W) | 23 cases/1150 kits | Class II | Terminated | 30 May 2018 |
| Z-1900-2018 | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z | 13 cases/1300 pads | Class II | Terminated | 30 May 2018 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.