Baxter Healthcare Corp. has 583 FDA recalls (110 Class I), 124 inspections, 570 510(k) clearances and 9 compliance actions on record.
What these totals cover: FDA records filed under the name "Baxter Healthcare Corp." and its spelling variants "Baxter Healthcare", "Baxter Healthcare Corporation", "Baxter Corporation", "Baxter". Records filed under related names are not included; see Related names.
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Record counts and when each FDA source was last refreshed
Records
Count
Last refreshed
Source as of
Status
Recalls
583 (110 Class I)
Nov 8, 2026
File dated Nov 3, 2026
Current
510(k) clearances
570
Nov 8, 2026
File dated Nov 2, 2026
Current
Inspections
124
Nov 13, 2026
Newest record Nov 5, 2026
Current
Compliance actions
9
Nov 2, 2026
Newest record Oct 29, 2026
Current
FDA record by year
Baxter Healthcare Corp.'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
3
1
1
37
9
2025
5
1
0
65
13
2024
4
2
0
87
24
2023
6
1
0
46
9
2022
3
0
0
74
9
2021
3
0
0
18
4
2020
1
0
0
34
4
2019
2
0
0
18
0
2018
6
0
0
37
0
2017
8
0
0
17
2
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.
Related names
Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Baxter Healthcare Corp. above.
FDA's compliance actions data lists 9 compliance actions under Baxter Healthcare Corp.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
Spectrum IQ Infusion System with Dose IQ Safety Software
Apr 29, 2022
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