Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 46 of 63
Trilliant Surgical Ltd.
Class II Terminated
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless...
Reason: Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Z-2464-2015 September 2, 2015 Houston, TX
Synthes (USA) Products LLC
Class II Terminated
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Unive...
Reason: The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.
Z-2425-2015 August 26, 2015 West Chester, PA
Advanced Sterilization Products
Class II Terminated
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
Reason: Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypro...
Z-2375-2015 August 19, 2015 Irvine, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2177-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2176-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2182-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2187-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable...
Z-2156-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2180-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical proced...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2162-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2174-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat a...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2170-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2169-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusabl...
Z-2166-2015 July 29, 2015 San Jose, CA
American Catheter Corp
Class II Terminated
American Catheter / Cholangiogram Catheter 9100 Series.
Reason: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Z-2191-2015 July 29, 2015 Ocala, FL
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical proced...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable...
Z-2163-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable...
Z-2158-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2184-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2172-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2185-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2173-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2167-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable S...
Z-2183-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusabl...
Z-2165-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical ...
Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable...
Z-2161-2015 July 29, 2015 San Jose, CA