Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 47 of 63
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpe...
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-2171-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 44S, 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-2181-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 550¿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-2168-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 18S, 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-2179-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 365 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-2159-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 12S, 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-2175-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 200 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-2157-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Sureflex 550 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-2160-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Tool, Stripper W/BLD, 18S, 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-2178-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Fiber Stripper, 150¿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...
Z-2164-2015 July 29, 2015 San Jose, CA
American Medical Systems Innovation Center - Silicon Valley
Class II Terminated
Stripper, 0.3mm 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-2186-2015 July 29, 2015 San Jose, CA
Advanced Sterilization Products
Class II Terminated
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level ...
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, a...
Z-1715-2015 June 17, 2015 Irvine, CA
Advanced Sterilization Products
Class II Terminated
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfec...
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, a...
Z-1714-2015 June 17, 2015 Irvine, CA
Zimmer, Inc.
Class II Terminated
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Reason: Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master ...
Z-1696-2015 June 10, 2015 Warsaw, IN
Steris Corporation
Class II Terminated
Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and ...
Reason: Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In...
Z-1559-2015 May 6, 2015 Mentor, OH
Steris Corporation
Class II Terminated
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-st...
Reason: STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown tim...
Z-1561-2015 May 6, 2015 Mentor, OH
Bacterin International, Inc.
Class II Terminated
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument ...
Reason: Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the ...
Z-1396-2015 April 15, 2015 Belgrade, MT
Medical Components, Inc dba MedComp
Class II Terminated
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon...
Reason: Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III beca...
Z-1351-2015 April 8, 2015 Harleysville, PA
Advanced Sterilization Products
Class II Terminated
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Reason: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
Z-1312-2015 April 1, 2015 Irvine, CA
Biomet Spine, LLC
Class II Terminated
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tu...
Reason: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Z-1146-2015 March 4, 2015 Broomfield, CO
Brainlab AG
Class II Terminated
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instr...
Reason: The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Z-1215-2015 March 4, 2015 Feldkirchen, N/A
Lacrimedics Inc
Class III Terminated
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1...
Reason: Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.
Z-1081-2015 February 18, 2015 DuPont, WA
Biomet Spine, LLC
Class II Terminated
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. ...
Reason: The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter dur...
Z-1089-2015 February 18, 2015 Broomfield, CO
Biomet Spine, LLC
Class II Terminated
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Ti...
Reason: Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
Z-1069-2015 February 18, 2015 Broomfield, CO
Medical Components, Inc dba MedComp
Class II Terminated
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PR...
Reason: Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule ...
Z-1083-2015 February 18, 2015 Harleysville, PA