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Hill-Rom Manufacturing, Inc.

FDA Regulatory Profile

Hill-Rom Manufacturing, Inc. has 2 FDA recalls, 4 inspections, 4 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Hill-Rom Manufacturing, Inc." and its spelling variant "Hill-Rom Manufacturing". Records filed under related names are not included; see Related names.

Latest recall: Z-0484-2021 · Class II · Nov 12, 2020
Latest inspection: Nov 21, 2013 · NAI
Latest 510(k): Apr 9, 2008

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	2	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	4	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hill-Rom Manufacturing, Inc.'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	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	1	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	1	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.

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 Hill-Rom Manufacturing, Inc. 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)
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	—
Gambro Lundia	Same company group	0	0	3	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 recalls

2 recall records from Sep 15, 2017 to Nov 12, 2020.

Number	Class	Product	Date
Z-0484-2021	Class II	Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118…	Nov 12, 2020
Z-0192-2018	Class II	Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability…	Sep 15, 2017

Recent FDA inspections

4 inspections from Apr 15, 2009 to Nov 21, 2013.

Date	Site	Product	Classification	FEI
Nov 21, 2013	Charleston, SC	Devices	No Action Indicated (NAI)	1045510
Feb 10, 2012	Charleston, SC	Devices	No Action Indicated (NAI)	1045510
Apr 15, 2009	Charleston, SC	Devices	Voluntary Action Indicated (VAI)	1045510
Apr 15, 2009	Charleston, SC	Devices	Voluntary Action Indicated (VAI)	1045510

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 1045510	Charleston, SC	4	Nov 21, 2013

Recent 510(k) clearances

4 510(k) clearances from Jan 11, 2002 to Apr 9, 2008.

K-Number	Device	Date
K080226	NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912	Apr 9, 2008
K032772	MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE…	Oct 8, 2003
K031387	ISOLETTE INFANT INCUBATOR, MODEL C2000E	Aug 1, 2003
K014094	MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM	Jan 11, 2002

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