CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin recalled by Remel
Remel is recalling Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package, distributed nationwide in the US. The recall was initiated on 22 Apr 2021 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-1561-2021
- FDA event ID
- 87830
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2021
- FDA classified
- 12 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 22 Apr 2021 | Recall initiated by company | |
| 12 May 2021 | Classified by FDA | +20 days |
| 19 May 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Where it was distributed
US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.
Nationwide ArizonaCaliforniaColoradoConnecticutGeorgiaIowaIllinoisIndianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNorth DakotaOhioOregonPennsylvaniaSouth DakotaTennesseeTexas
Questions about this recall
Why was it recalled?
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Which lots are affected?
Lot #248035, Exp. 2021-04-27
Where was it sold?
US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign 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 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.
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