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Hill-Rom Manufacturing, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 2183816

Devices
4
Registrations
FDA
FDA recalls
20

What Hill-Rom Manufacturing, Inc. makes

Hill-Rom Manufacturing, Inc. produces obstetrical patient data management systems, including the NaviCare-WatchChild system and its modifications, designed for monitoring and recording maternal and fetal health metrics during labor and delivery. The company also manufactures the Isolette Infant Incubator, Model C2000E, a device for maintaining controlled environments for newborns requiring specialized care.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

Company details

FDA FEI number
2183816
Address
1020 COUNTY ROAD F W, SAINT PAUL, MN, 55126

FDA recalls20

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 20 recalls initiated by HILL-ROM MANUFACTURING, INC., the earliest on 2002-01-14 and the most recent on 2020-11-12. By recorded status: 20 terminated. The reasons filed fall into these groups: software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

18 initiated before 2017

Showing the 10 most recent of 20 recalls.

  • 2020

    • 12 Nov 2020 Z-0484-2021 Class II Terminated Under certain conditions, there is a risk for fire. Distribution: US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX,…
      Full distribution text US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.
      Submission number: K170037

  • 2017

    • 15 Sep 2017 Z-0192-2018 Class II Terminated Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device. Distribution: USA (nationwide) Distribution to the states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH, OK, OR,…
      Full distribution text USA (nationwide) Distribution to the states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, VA, WA, WI, and WV. Internationally to Canada. There was no military/government distribution.
      Submission number: K163378

  • 2010

    • 6 Dec 2010 Z-1253-2011 Unclassified (pre-2012) Terminated Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. Distribution: Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA Submission number: K863047
    • 6 Dec 2010 Z-1254-2011 Unclassified (pre-2012) Terminated Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. Distribution: Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA Submission number: K863047

  • 2009

    • 24 Jun 2009 Z-1902-2009 Unclassified (pre-2012) Terminated Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. Distribution: Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico,…
      Full distribution text Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
      Submission number: K813584
    • 24 Jun 2009 Z-1903-2009 Unclassified (pre-2012) Terminated Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. Distribution: Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico,…
      Full distribution text Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
      Submission number: K920112
    • 12 May 2009 Z-1874-2009 Unclassified (pre-2012) Terminated The devices may emit smoke from the blower box assembly. Distribution: Nationwide and Canada Submission number: K863047
    • 12 May 2009 Z-1875-2009 Unclassified (pre-2012) Terminated The devices may emit smoke from the blower box assembly. Distribution: Nationwide and Canada Submission number: K863047

  • 2008

    • 9 Oct 2008 Z-0600-2009 Unclassified (pre-2012) Terminated These devices have the potential to overheat. Distribution: Nationwide Distribution.
    • 9 Oct 2008 Z-0601-2009 Unclassified (pre-2012) Terminated These devices have the potential to overheat. Distribution: Nationwide Distribution.
Show all 20 recalls

  • 2008

    • 9 Oct 2008 Z-0602-2009 Unclassified (pre-2012) Terminated These devices have the potential to overheat. Distribution: Nationwide Distribution.
    • 9 Oct 2008 Z-0603-2009 Unclassified (pre-2012) Terminated These devices have the potential to overheat. Distribution: Nationwide Distribution.
    • 19 Jun 2008 Z-0088-2009 Unclassified (pre-2012) Terminated A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly. Distribution: Worldwide Distribution --- including USA and country of Canada.

  • 2005

    • 20 May 2005 Z-1555-05 Unclassified (pre-2012) Terminated Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator. Distribution: AL, FL, KY, LA, MA, NC, NY, TN, TX, VA Submission number: K942184

  • 2004

    • 4 Mar 2004 Z-0810-04 Unclassified (pre-2012) Terminated Bed may pose a health hazard due to: A) Inability to articulate the frame during transport, B) Exposed sharp edge of footplate, C) Shear point between seat section and lymph panel and D) Patient fall. Distribution: The Magnum II Bariatric Patient System is primarily leased by hospitals, although some units have been sold Nationwide…
      Full distribution text The Magnum II Bariatric Patient System is primarily leased by hospitals, although some units have been sold Nationwide and Canada.

  • 2003

    • 27 Aug 2003 Z-0058-04 Unclassified (pre-2012) Terminated Reports of patient entrapment between mattress and side-rails. Distribution: Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K. Submission number: K863047
    • 27 Aug 2003 Z-0059-04 Unclassified (pre-2012) Terminated Reports of patient entrapment between mattress and side-rails. Distribution: Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
    • 5 May 2003 Z-0989-03 Unclassified (pre-2012) Terminated Malfunction of side-rail latching pin coupled with inadequate directions for use. Distribution: The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada,…
      Full distribution text The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.
      Submission number: K813584
    • 5 May 2003 Z-0990-03 Unclassified (pre-2012) Terminated Malfunction of side-rail latching pin coupled with inadequate directions for use. Distribution: The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada,…
      Full distribution text The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.
      Submission number: K920112

  • 2002

    • 14 Jan 2002 Z-0057-04 Unclassified (pre-2012) Terminated Power cord overheating Distribution: Hill Rom primarily leases these units to home care patients and some are sold nationwide. Submission number: K942184

Frequently asked questions

How many devices does HILL-ROM MANUFACTURING, INC. have in the registry?

The registry currently lists 4 devices for HILL-ROM MANUFACTURING, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list HILL-ROM MANUFACTURING, INC.'s devices?

Among its 4 most recently registered devices, HILL-ROM MANUFACTURING, INC. has devices listed in FDA 510(k) (4 devices).

What risk classes do HILL-ROM MANUFACTURING, INC.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for HILL-ROM MANUFACTURING, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for HILL-ROM MANUFACTURING, INC.?

FDA recall records list 20 recalls initiated by HILL-ROM MANUFACTURING, INC., the most recent initiated on 12 Nov 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from HILL-ROM MANUFACTURING, INC. in the registry?

The most recently registered devices listed for HILL-ROM MANUFACTURING, INC. include MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM, NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912, ISOLETTE INFANT INCUBATOR, MODEL C2000E and MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.