Apparatus, Suction, Single Patient Use, Portable, Nonpowered
FDA adverse event reports and recall history for apparatus, suction, single patient use, portable, nonpowered (product code GCY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,691
- Deaths
- 13
- Injuries
- 1,606
- Malfunctions
- 2,857
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-02-08TerminatedLabeling mix-ups
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
An incorrect sterility status on the label, non-sterile products labeled as sterile
- 2017-02-08TerminatedLabeling mix-ups
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
An incorrect sterility status on the label, non-sterile products labeled as sterile
- 2016-05-27TerminatedManufacturing material removal
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
- 2015-07-24TerminatedOther
Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
- 2015-07-24TerminatedOther
Medical Device Exchange - Auto Suture Endo Universal 65 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
- 2015-05-13TerminatedOther
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
- 2015-05-01TerminatedPackage design/selection
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- 2015-05-01TerminatedPackage design/selection
3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- 2015-05-01TerminatedPackage design/selection
1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- 2015-05-01TerminatedPackage design/selection
1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Monitor apparatus, suction, single patient use, portable, nonpowered automatically
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