The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2545-2018·Announced 2018-08-01

Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (mold growth in sterile media) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Life Technologies, Corp. is recalling 91 units of Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. The affected product is a tissue and cell culture medium with Lot number 1945238.

The recall was initiated because the fill port tube seal integrity was compromised during manufacture. This defect may cause the media to leak from the primary sterile packaging into the outer non-sterile dust cover packaging, creating conditions where mold may grow in the pooled, leaked media.

The product was distributed worldwide, including in the United States (CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA) and in Canada, France, Great Britain, Japan, Korea, the Netherlands, and Switzerland. Users should check their inventory for the specific lot number and discontinue use if found.

The recalled product

Product
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
Manufacturer
Life Technologies, Corp.
Category
Medical Device — Tissue Culture Media
Hazard
Affected units
91

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 1945238

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 6 recalled by Life Technologies, Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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