Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 17 of 63
Medline Industries Inc
Class II Terminated
Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Manageme...
Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Z-0065-2021 October 14, 2020 Northfield, IL
Biomet, Inc.
Class II Terminated
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Z-0084-2021 October 14, 2020 Warsaw, IN
Biomet, Inc.
Class II Terminated
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Z-0083-2021 October 14, 2020 Warsaw, IN
Biomet, Inc.
Class II Terminated
Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Z-0082-2021 October 14, 2020 Warsaw, IN
Medline Industries Inc
Class II Terminated
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management f...
Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Z-0066-2021 October 14, 2020 Northfield, IL
Medline Industries Inc
Class II Terminated
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management f...
Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Z-0061-2021 October 14, 2020 Northfield, IL
Medline Industries Inc
Class II Terminated
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Manag...
Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Z-0062-2021 October 14, 2020 Northfield, IL
Biomet, Inc.
Class II Terminated
Biomet Regenerex Primary Taper Cap Item Number 141269
Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Z-0081-2021 October 14, 2020 Warsaw, IN
Integra LifeSciences Corp.
Class II Terminated
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for pro...
Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Z-2955-2020 September 23, 2020 Princeton, NJ
Integra LifeSciences Corp.
Class II Terminated
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/...
Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Z-2953-2020 September 23, 2020 Princeton, NJ
Integra LifeSciences Corp.
Class II Terminated
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional...
Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Z-2954-2020 September 23, 2020 Princeton, NJ
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for ai...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2897-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for ai...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2896-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding ...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2890-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding ...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2893-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for ai...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2891-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding ...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2892-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for ai...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2895-2020 September 2, 2020 El Segundo, CA
Karl Storz Endoscopy
Class II Ongoing
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for ai...
Reason: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable ...
Z-2894-2020 September 2, 2020 El Segundo, CA
Sutter Medizintechnik GmbH
Class II Terminated
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and d...
Reason: The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. ...
Z-2744-2020 August 12, 2020 Freiburg Im Breisgau
Resource Optimization & Innovation LLC
Class II Terminated
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of s...
Reason: The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
Z-2699-2020 August 5, 2020 Saint Louis, MO
Smith & Nephew, Inc.
Class II Terminated
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Reason: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Z-2685-2020 July 29, 2020 Memphis, TN
Medtronic Perfusion Systems
Class II Terminated
Extra corporeal circuit with bio-active surface.
Reason: Affected products failed a sterilization test.
Z-2495-2020 July 15, 2020 Brooklyn Park, MN
Biomet
Class II Terminated
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Reason: Device and tray that houses the device did not pass steam sterilization process validation testing
Z-2362-2020 June 24, 2020 Miami, FL
Biomet
Class II Terminated
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Reason: Device and tray that houses the device did not pass steam sterilization process validation testing
Z-2363-2020 June 24, 2020 Miami, FL