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Smiths Medical Pm, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
49

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Smiths Medical Pm, Inc. makes

Smiths Medical Pm, Inc. manufactures pulse oximeters, including standalone and digital models such as the WW1000, WW1020, and AUTOCON 3304, as well as a PC-based application (BCI WW1021) for monitoring oxygen saturation and pulse rate.

These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.

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

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls49

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 49 recalls initiated by Smiths Medical Pm, Inc., the earliest on 2005-01-05 and the most recent on 2010-01-15. By recorded status: 49 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. 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.

Showing the 10 most recent of 49 recalls.

  • 2010

    • 15 Jan 2010 Z-0918-2010 Unclassified (pre-2012) Terminated Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq Distribution: US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY,…
      Full distribution text US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY. Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.
      Submission number: K030407
    • 15 Jan 2010 Z-0919-2010 Unclassified (pre-2012) Terminated Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq Distribution: US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY,…
      Full distribution text US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY. Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.
      Submission number: K020350
    • 15 Jan 2010 Z-0920-2010 Unclassified (pre-2012) Terminated Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq Distribution: US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY,…
      Full distribution text US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY. Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.
      Submission number: K991086

  • 2008

    • 22 Dec 2008 Z-1326-2009 Unclassified (pre-2012) Terminated Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported. Distribution: Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador,…
      Full distribution text Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay.
      Submission numbers: K010770, K011177, K030407, K982279
    • 2 Apr 2008 Z-1649-2008 Unclassified (pre-2012) Terminated Due to a component that may be installed backwards, the device may turn off or may immediately reset. Distribution: USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada,…
      Full distribution text USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom
      Submission numbers: K031742, K970801, K983796, K984618
    • 27 Feb 2008 Z-1619-2008 Unclassified (pre-2012) Terminated The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to Distribution: Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL,…
      Full distribution text Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL, AZ, OH, CA, MS, UT and Countries: Argentina, Bangladesh, Iran, Thailand, Mexico, India, Germany, Guatemala, Pakistan, Chile, Colombia, Brazil, Saudi Arabia, Morocco, Kuwait, Trinidad and Tobago, Ecuador, Paraguay, Uruguay, Canada, Poland, Portugal, Peru, Qatar, Cyprus, Greece, Italy, Spain, United Arab Emirates, Israel.
      Submission number: K020350

  • 2007

    • 18 Jul 2007 Z-1240-2007 Unclassified (pre-2012) Terminated Phantom pacer spikes caused by a damaged resistor. Distribution: World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore,…
      Full distribution text World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.
      Submission number: K981939
    • 5 Jun 2007 Z-1089-2007 Unclassified (pre-2012) Terminated Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on. Distribution: International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany,…
      Full distribution text International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
      Submission numbers: K010770, K030407, K982279
    • 16 May 2007 Z-0991-2007 Unclassified (pre-2012) Terminated Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient. Distribution: Nationwide. Submission number: K051322

  • 2006

    • 6 Nov 2006 Z-0300-2007 Unclassified (pre-2012) Terminated An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes. Distribution: Worldwide, including USA, Puerto Rico, Argentina, Bolivia, Brunei, Chile, China, Columbia, Czech Republic, Germany,…
      Full distribution text Worldwide, including USA, Puerto Rico, Argentina, Bolivia, Brunei, Chile, China, Columbia, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Kuwait, Mexico, Netherlands, Poland, Romania, Singapore, Spain, Taiwan, and United Kingdom.
      Submission number: K981939
Show the 25 most recent of 49 recalls

  • 2005

    • 5 Dec 2005 Z-0436-06 Unclassified (pre-2012) Terminated A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose. Distribution: CA, CO, IN,MN, NY, PA, TN, TX
    • 1 Sep 2005 Z-0220-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0221-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0222-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0223-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0224-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0225-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0226-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0227-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0228-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0229-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0230-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0231-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0232-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279
    • 1 Sep 2005 Z-0233-06 Unclassified (pre-2012) Terminated Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain Submission numbers: K010770, K011177, K030407, K982279

Frequently asked questions

How many devices does Smiths Medical Pm, Inc. have in the registry?

The registry currently lists 5 devices for Smiths Medical Pm, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Smiths Medical Pm, Inc.'s devices?

Among its 5 most recently registered devices, Smiths Medical Pm, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Smiths Medical Pm, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Smiths Medical Pm, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Smiths Medical Pm, Inc.?

FDA recall records list 49 recalls initiated by Smiths Medical Pm, Inc., the most recent initiated on 15 Jan 2010. 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 Smiths Medical Pm, Inc. in the registry?

The most recently registered devices listed for Smiths Medical Pm, Inc. include BCI WW1021 PC APPLICATION, BCI WW1030 PULSE OXIMETER, BCI WW1020 PULSE OXIMETER, MODEL WW1020 and BCI AUTOCON 3304 DIGITAL PULSE OXIMETER.

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