CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose recalled
Life Technologies is recalling Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, distributed in 11 states. The recall was initiated on 10 May 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-2547-2018
- FDA event ID
- 80380
- Recalling firm
- Life Technologies, Grand Island, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2018
- FDA classified
- 25 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Mold
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 10 May 2018 | Recall initiated by company | |
| 25 Jul 2018 | Classified by FDA | +76 days |
| 1 Aug 2018 | 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
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Product as listed by the FDA
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
Where it was distributed
Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.
CaliforniaColoradoConnecticutFloridaGeorgiaMassachusettsMarylandPennsylvaniaRhode IslandUtahWashington
Questions about this recall
Is Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate recalled?
Yes. Life Technologies recalled Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate on 10 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2547-2018.
Why was it recalled?
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Which lots are affected?
Lot: 1932659
Where was it sold?
Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.
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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