Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 56 of 63
Stryker Endoscopy
Class II Terminated
PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliar...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0784-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgi...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0715-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgica...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0617-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical a...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0737-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surg...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0624-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, BABCOCK FORCEPS, P/N 0250080321. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as sutu...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0684-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliarie...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0755-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgica...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0651-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliari...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0652-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries ...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0668-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as sutur...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0609-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliari...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0701-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxi...
Reason: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyle...
Z-0735-2015 December 24, 2014 San Jose, CA
Gyrus Acmi, Incorporated
Class II Terminated
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a st...
Reason: All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to...
Z-0419-2015 December 3, 2014 Southborough, MA
Biomet Spine LLC.
Class II Terminated
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft...
Reason: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Z-0220-2015 November 26, 2014 Broomfield, CO
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2729-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2724-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2726-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2728-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2730-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2723-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2721-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2727-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2722-2014 October 8, 2014 Schaumburg, IL
Instrumed International, Inc.
Class II Terminated
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to pro...
Reason: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must ...
Z-2725-2014 October 8, 2014 Schaumburg, IL