CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP recalled
Madison Polymeric Engineering is recalling First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. The recall was initiated on 3 Nov 2017 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-1182-2018
- FDA event ID
- 79402
- Recalling firm
- Madison Polymeric Engineering, Branford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2017
- FDA classified
- 26 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 3 Nov 2017 | Recall initiated by company | |
| 26 Mar 2018 | Classified by FDA | +143 days |
| 4 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected lots may have exceeded its microbial limits.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
Where it was distributed
US Distribution. .
Questions about this recall
Is First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4 recalled?
Yes. Madison Polymeric Engineering recalled First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4 on 3 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-1182-2018.
Why was it recalled?
Affected lots may have exceeded its microbial limits.
Which lots are affected?
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
Where was it sold?
US Distribution. .
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
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Draco Enzymatic Deep-Cleaning Pad recalled | Madison Polymeric Engineering | Other | 13 states |
| Device | CLASS II | First Step Draco Pad, Product Number EP-4D recalled | Madison Polymeric Engineering | Other | 13 states |
| Device | CLASS II | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z recalled | Madison Polymeric Engineering | Sterility | 8 states |
| 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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| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |