FDA Medical Device Recalls (openFDA)
Global Cooling Inc: Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.
- Recall number
- Z-1940-2014
- Recalling firm
- Global Cooling Inc
- Product
- Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.
- Status
- Terminated
- Initiated
- 2014-03-20
- Posted
- 2014-07-01
- Terminated
- 2015-07-01
- Reason
- The external power supply input is overheating at the connection to the freezer.
- Root cause
- Use error
- Action
- Consignees received an Urgent Medical Device Recall letter, dated March 20, 2014, a Recall Response letter, a User Alert, and a label to attach to the freezer power supply input. The letter identified the reason for the recall and how to recognize that the device may fail. Customers are to discontinue use of the device if there are any signs of a loose connection, corrosion, discoloration, or melting; and take the necessary actions identified, including contacting Global Cooling Customer Service at service@stirlingultracold.com. The Recall Return Response was to be completed and returned.
- Quantity
- 413 units
- Distribution
- Worldwide Distribution -- USA, including the states of AK, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Australia, Brazil, Canada, China, India, Indonesia, Japan, Korea, Kuwait, Mexico, Netherlands, Pakistan, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
- Lot, serial or model codes
- Codes: ULT-25-255 & ULT-25-713
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JRM
- Firm FEI
- 3001246104
- Firm city
- Athens
- Firm state
- OH
- 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