FDA Medical Device Recalls (openFDA)
Life Technologies, Corp.: Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
- Recall number
- Z-2544-2018
- Recalling firm
- Life Technologies, Corp.
- Product
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
- Status
- Terminated
- Initiated
- 2018-05-10
- Posted
- 2018-07-25
- Terminated
- 2020-05-05
- Reason
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- Urgent Medical Device Recall Notification letters dated 6/28/18 were distributed to customers to notify them of the recall of GIBCO CTS AIM V Serum-Free Media (SFM); Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate; Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose; and Gibco RPMI 1640 Medium. The letters instructed customers to do the following: For the above mentioned lots of product, please complete an inspection of the seal integrity of your inventory. There should not be visual evidence of media within the space between the media bag itself and the dust cover. If you are using product that was manufactured between the dates noted above and you have confirmed media between the media bag and dust cover, we ask that you dispose of these bags per local and state requirements and complete the attached Customer Response Form. As noted above, for bags that do not have any visible media beyond the seal, we have confirmed through sterility testing that these units meet sterility specifications and are acceptable for use. Please inform all affected users within your organization of this notification. If you have used this product in manufacturing, you must notify impacted customers and impacted facilities of this notice and our concern for the potential of fill tube seal integrity loss. Please complete the following Customer Response Sheet if you have product that was manufactured between September 2017 and December 2017 and you have confirmed visual evidence of media between the media bag and dust cover. We will work with you to ensure that you receive credit for the discarded material. North American customers: Please complete the following Customer Response Sheet if you have confirmed visual evidence of at the bag-port or media between the media bag and dust cover in your material. Email a scanned copy of the response sheet along with this letter to customer.relations@thermofisher.com. If you have any questions, please ca
- Quantity
- 45
- Distribution
- 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.
- Lot, serial or model codes
- Lot: 1932659
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDS
- Firm FEI
- 1317268
- Firm city
- Grand Island
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28