Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 34 of 63
Akita Sumitomo Bakelite Co., Ltd.
Class II Terminated
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W...
Reason: Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Z-0389-2017 November 16, 2016 Akita
Spiegelberg Gmbh & Co. KG
Class II Terminated
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intr...
Reason: In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measu...
Z-2888-2016 October 5, 2016 Hamburg, N/A
Nakanishi Inc.
Class II Terminated
Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in additio...
Reason: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that...
Z-2673-2016 September 7, 2016 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ul...
Reason: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that...
Z-2672-2016 September 7, 2016 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the...
Reason: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that...
Z-2674-2016 September 7, 2016 Kanuma, N/A
Stryker Howmedica Osteonics Corp.
Class II Terminated
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Reason: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Z-2281-2016 August 3, 2016 Mahwah, NJ
Ceg Enterprises Llc
Class II Terminated
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a...
Reason: CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could ...
Z-2047-2016 June 29, 2016 Hopkins, MN
Greatbatch Medical
Class II Terminated
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: ...
Reason: Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (S...
Z-1883-2016 June 8, 2016 Plymouth, MN
Greatbatch Medical
Class II Terminated
Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S...
Reason: Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (S...
Z-1882-2016 June 8, 2016 Plymouth, MN
Greatbatch Medical
Class II Terminated
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T1162...
Reason: Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (S...
Z-1884-2016 June 8, 2016 Plymouth, MN
Applied Medical Technology Inc
Class II Terminated
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1608-2016 May 11, 2016 Brecksville, OH
Applied Medical Technology Inc
Class II Terminated
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1611-2016 May 11, 2016 Brecksville, OH
Applied Medical Technology Inc
Class II Terminated
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue re...
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1610-2016 May 11, 2016 Brecksville, OH
Applied Medical Technology Inc
Class II Terminated
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1609-2016 May 11, 2016 Brecksville, OH
Customed, Inc
Class II Terminated
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1423-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1480-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1495-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1459-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1496-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1412-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1465-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1477-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, ...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1489-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1400-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1401-2016 April 20, 2016 Fajardo, PR