CLASS II Device recall · Reported 30 May 2018 · FDA Enforcement Report
Travel Kit, First Step EP-4 Kit and 1 Soiled Scope Bag recalled
Madison Polymeric Engineering is recalling Travel Kit, First Step EP-4 Kit and 1 Soiled Scope Bag (White), Flexible Endoscope, distributed in 40 states. The recall was initiated on 21 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1899-2018
- FDA event ID
- 79826
- Recalling firm
- Madison Polymeric Engineering, Branford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2018
- FDA classified
- 18 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 21 Mar 2018 | Recall initiated by company | |
| 18 May 2018 | Classified by FDA | +58 days |
| 30 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
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, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
AlaskaAlabamaArkansasCaliforniaConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Is Travel Kit, First Step EP-4 Kit and 1 Soiled Scope Bag (White), Flexible Endoscope recalled?
Yes. Madison Polymeric Engineering recalled Travel Kit, First Step EP-4 Kit and 1 Soiled Scope Bag (White), Flexible Endoscope on 21 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1899-2018.
Why was it recalled?
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Which lots are affected?
Lot Numbers: EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, EX20181229P
Where was it sold?
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, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Madison Polymeric Engineering
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|---|---|---|---|---|---|
| Device | CLASS II | Draco Enzymatic Deep-Cleaning Pad recalled | Madison Polymeric Engineering | Other | 13 states |
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| Device | CLASS II | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused recalled | Madison Polymeric Engineering | Sterility | 40 states |
| Device | CLASS II | First Step Endoscopic Cleaning Pad with 4" Button Brush recalled | Madison Polymeric Engineering | Sterility | 40 states |
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