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Gambro Lundia AB

FDA Regulatory Profile

Gambro Lundia AB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Gambro Lundia AB" and its spelling variant "Gambro Lundia". Records filed under related names are not included; see Related names.

Latest inspection: Jan 26, 2017 · NAI

Newer recall under related name Baxter Healthcare Corporation: Sep 14, 2026, Z-0151-2027.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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 Gambro Lundia AB above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Baxter Healthcare Corporation Combines 2 spellings Baxter Healthcare Corporation: 439 recalls, 61 510(k)s, 106 inspections, 9 compliance actions Baxter Healthcare: 144 recalls, 508 510(k)s, 12 inspections	Same company group	583	569	118	9	Sep 14, 2026 (Z-0151-2027)
Hill-Rom Combines 2 spellings Hill-Rom: 37 recalls, 37 510(k)s, 13 inspections, 1 compliance action Hill-Rom Company: 1 inspection	Same company group	37	37	14	1	Jan 14, 2022 (Z-0783-2022)
Welch Allyn	Same company group	5	112	7	0	Jul 20, 2021 (Z-2482-2021)
Hill-Rom Manufacturing	Same company group	2	4	4	0	Nov 12, 2020 (Z-0484-2021)
Gambro Renal Products Combines 2 spellings Gambro Renal Products, Incorporated: 18 recalls, 2 inspections Gambro Renal Products: 2 recalls, 37 510(k)s, 2 inspections	Same company group	20	37	4	0	Nov 5, 2014 (Z-0490-2015)
Gambro	Same company group	0	87	0	0	—
Gambro Healthcare	Same company group	0	13	0	0	—
Gambro Dasco Spa Monitors Division	Same company group	0	0	4	1	—
Baxter	Same company group	0	1	2	0	—
Hillrom Manufacturing	Same company group	0	0	3	0	—
Baxter R And D Europe	Same company group	0	0	2	0	—
Baxter Sales And Distribution	Same company group	0	0	2	0	—

Recent FDA inspections

3 inspections from Mar 5, 2009 to Jan 26, 2017.

Date	Site	Product	Classification	FEI
Jan 26, 2017	Lund, Sweden	Devices	No Action Indicated (NAI)	3002807039
Dec 18, 2014	Lund, Sweden	Devices	Voluntary Action Indicated (VAI)	3002807039
Mar 5, 2009	Lund, Sweden	Devices	No Action Indicated (NAI)	3002807039

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807039	Lund, Sweden	3	Jan 26, 2017

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