HILL-ROM MANUFACTURING, INC. — FDA Facility Profile
HILL-ROM MANUFACTURING, INC. is an FDA-registered facility (FEI 2183816) located in SAINT PAUL, MN, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: No Action Indicated (NAI)
- Inspections on record
- 3 (3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Nov 12, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | No Action Indicated (NAI) | No citations listed |
| Apr 26, 2022 | No Action Indicated (NAI) | No citations listed |
| Jan 29, 2020 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 12, 2020 | Class II | Z-0484-2021 | Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model… Under certain conditions, there is a risk for fire. |
| Sep 15, 2017 | Class II | Z-0192-2018 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth… Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as… |
Facility details
- Company
- Hillrom Manufacturing, Inc.
- Location
- SAINT PAUL, MN (US)
- Source
- device