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Ross Products Division

FDA adverse event reports naming Ross Products Division as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ROSS PRODUCTS DIVISION.

Total reports
1,610
Deaths
1
Injuries
23
Malfunctions
1,585

Reports per year

95
96
97
98
02
03
04
06
07
08

Source: FDA adverse event reports by year received, 19952008. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Recent recalls

  • 2007-08-08TerminatedEquipment maintenance

    Embrace Enteral Pump

    Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.

  • 2007-08-07TerminatedEquipment maintenance

    The Companion ClearStar Pump System, for enteral feeding.

    The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.

  • 2007-07-10TerminatedOther

    Patrol enteral pump set with piercing pin, list #520540.

    The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.

  • 2005-03-08TerminatedOther

    Flexiflo Quantum Enteral Pump

    Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

  • 2004-07-20TerminatedOther

    Ross 14 FR Gastrostomy Tube, Item #152.

    An increase in reported balloon failures, which may result in tube displacement.

  • 2004-07-20TerminatedOther

    Ross 16 FR Gastrostomy Tube, Item #153.

    An increase in reported balloon failures, which may result in tube displacement.

  • 2004-07-20TerminatedOther

    Ross 18 FR Gastrostomy Tube, Item #154.

    An increase in reported balloon failures, which may result in tube displacement.

  • 2004-07-20TerminatedOther

    Ross 20 FR Gastrostomy Tube, Item #155.

    An increase in reported balloon failures, which may result in tube displacement.

  • 2004-07-20TerminatedOther

    Ross 22 FR Gastrostomy Tube, Item #156.

    An increase in reported balloon failures, which may result in tube displacement.

  • 2004-07-20TerminatedOther

    Ross 24 FR Gastrostomy Tube, Item #159.

    An increase in reported balloon failures, which may result in tube displacement.

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