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Record counts and when each FDA source was last refreshed
Records
Count
Last refreshed
Source as of
Status
Recalls
2 (1 Class I)
Nov 8, 2026
File dated Nov 3, 2026
Current
510(k) clearances
0
Nov 8, 2026
File dated Nov 2, 2026
Current
Inspections
5
Nov 14, 2026
Newest record Nov 5, 2026
Current
Compliance actions
0
Nov 2, 2026
Newest record Oct 29, 2026
Current
FDA record by year
Heinens'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
1
0
0
0
0
2025
0
0
0
0
0
2024
0
0
0
1
0
2023
0
0
0
1
1
2022
0
0
0
0
0
2021
0
0
0
0
0
2020
0
0
0
0
0
2019
1
0
0
0
0
2018
1
0
0
0
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
2 recall records from Jul 13, 2023 to May 30, 2024.
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