FDA Medical Device Recalls (openFDA)
Insulet Corporation: Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
- Recall number
- Z-0347-2020
- Recalling firm
- Insulet Corporation
- Product
- Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
- Status
- Terminated
- Initiated
- 2018-12-18
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
- Root cause
- Software design
- Action
- Urgent Medical Device Correction letters dated 12/18/18 were sent to customers.
- Quantity
- 264
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136
- 510(k) numbers
- ["K180045"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3004464228
- Firm city
- Billerica
- Firm state
- MA
- 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