CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report
Amsco 3000 Series Washer/Disinfector recalled by Steris
Steris is recalling Amsco 3000 Series Washer/Disinfector, distributed in 27 states. The recall was initiated on 20 Dec 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-0995-2019
- FDA event ID
- 82035
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2018
- FDA classified
- 8 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2018 | Recall initiated by company | |
| 8 Mar 2019 | Classified by FDA | +78 days |
| 20 Mar 2019 | 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 software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
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
AMSCO 3000 Series Washer/Disinfector Model # 3052
Where it was distributed
The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
AlabamaArkansasCaliforniaColoradoFloridaGeorgiaIllinoisLouisianaMassachusettsMarylandMaineMichiganNorth CarolinaNew JerseyNew MexicoNew YorkOklahomaOregonPennsylvaniaSouth Carolina
Questions about this recall
Why was it recalled?
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
Which lots are affected?
Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
Where was it sold?
The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82035This product is part of a recall event; the main page for the event is Amsco 5000 Series Washer/Disinfector recalled by Steris.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Amsco 5000 Series Washer/Disinfector recalled by Steris | Steris | Device Malfunction | 27 states |
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|---|---|---|---|---|---|
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