Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 31 of 63
Steris Corporation
Class II Terminated
Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provi...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0747-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0755-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0766-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0756-2018 March 7, 2018 Mentor, OH
Angiodynamics, Inc.
Class II Terminated
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is ...
Reason: Product was placed into distribution prior to completion of all required post sterilization release activities.
Z-0742-2018 March 7, 2018 Queensbury, NY
Steris Corporation
Class II Terminated
Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0759-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0767-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0751-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0752-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0765-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provid...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0746-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Reason: Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Z-0772-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0758-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0770-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0764-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0743-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0762-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0750-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0769-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0771-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0760-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0754-2018 March 7, 2018 Mentor, OH
Smiths Medical ASD, Inc.
Class II Terminated
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Reason: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Z-0577-2018 February 21, 2018 Gary, IN
Covidien LP
Class II Terminated
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internal...
Reason: Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the prod...
Z-0534-2018 February 14, 2018 Augusta, GA
Microline Surgical, Inc.
Class II Terminated
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic an...
Reason: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if caut...
Z-0507-2018 February 14, 2018 Beverly, MA