Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 54 of 63
Stryker Endoscopy
Class II Terminated
PKG, OBTURATOR, 11MM, FOR HASSON CANNULA, P/N 0250080158. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical aux...
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-0664-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, DISSECTING & GRASPER FORCEPS, SERRATED, 45CM, P/N 0250080579 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ are...
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-0706-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxil...
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-0732-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and ...
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-0610-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxili...
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-0666-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 3MM INSERT, FUNDUS GRASPER, 20CM, P/N 0250282003 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-0761-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries su...
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-0636-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; 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-0601-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical...
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-0739-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 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-0595-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxilia...
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-0650-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxil...
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-0725-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries s...
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-0700-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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-0691-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and sur...
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-0698-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, FUNDUS FORCEPS, P/N 0250080315. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as sutur...
Reason: Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000...
Z-0678-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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-0634-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical aux...
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-0759-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, NEEDLE NOSE FORCEPS, P/N 0250080048. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as...
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-0640-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 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-0712-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as ...
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-0599-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical ...
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-0713-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxili...
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-0646-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM, P/N 0250282005 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical aux...
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-0763-2015 December 24, 2014 San Jose, CA
Stryker Endoscopy
Class II Terminated
PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 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-0786-2015 December 24, 2014 San Jose, CA