CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
ProSpore Ampoule Biological indicator recalled by Mesa Laboratories
Mesa Laboratories is recalling ProSpore Ampoule Biological indicator for steam sterilization, contains Geobacillus, distributed nationwide in the US. The recall was initiated on 4 Apr 2016 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-1104-2017
- FDA event ID
- 76101
- Recalling firm
- Mesa Laboratories, Omaha, NE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2016
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 4 Apr 2016 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +297 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product resistance has fallen outside of label claim within expiry.
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
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Where it was distributed
Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
Nationwide AlabamaArkansasCaliforniaFloridaIowaMissouriNorth CarolinaNebraskaNew YorkOhioWashington
Questions about this recall
Is ProSpore Ampoule Biological indicator for steam sterilization, contains Geobacillus recalled?
Yes. Mesa Laboratories recalled ProSpore Ampoule Biological indicator for steam sterilization, contains Geobacillus on 4 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1104-2017.
Why was it recalled?
Product resistance has fallen outside of label claim within expiry.
Which lots are affected?
Lot # 637, exp. date 12/2016
Where was it sold?
Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military 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.
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