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Record counts and when each FDA source was last refreshed
Records
Count
Last refreshed
Source as of
Status
Recalls
21 (10 Class I)
Nov 8, 2026
File dated Nov 3, 2026
Current
510(k) clearances
25
Nov 8, 2026
File dated Nov 2, 2026
Current
Inspections
10
Nov 13, 2026
Newest record Nov 5, 2026
Current
Compliance actions
1
Nov 2, 2026
Newest record Oct 29, 2026
Current
FDA Record by Year
Insulet Corporation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).
Year
Inspections
OAI
Warning letters
Recall records
Class I
2026
0
0
0
4
4
2025
1
0
0
2
0
2024
0
0
0
0
0
2023
1
0
0
2
1
2022
0
0
0
2
1
2021
1
0
0
1
0
2020
0
0
0
3
0
2019
0
0
0
0
0
2018
1
0
0
1
0
2017
0
0
0
0
0
Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.
Recent Recalls
21 recall records from Sep 27, 2013 to May 20, 2026. Showing the 20 most recent. View all 21 recall records
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
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