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U.S. Department of Health and Human Services

Medical Device Recalls

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OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected... 2 06/22/2006 bioMerieux Inc
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only*... 2 08/08/2012 Biomet 3i, LLC
***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx On... 2 11/08/2011 Biomet 3i, LLC
"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERIL... 3 07/13/2011 Biomet 3i, LLC
***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***B... 2 05/24/2011 Biomet 3i, LLC
***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET... 2 05/04/2011 Biomet 3i, LLC
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, ... 2 10/05/2011 Biomet Microfixation, Inc.
Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfi... 2 05/27/2009 Biomet Microfixation, Inc.
10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. ... 2 03/25/2016 Biomet Spine, LLC
HipLOC Hip Fracture Fixation System-Hiploc System 135® Plate 38 mm Barrel 3 Hole Plate Item Numbe... 2 09/27/2018 Biomet UK Ltd.
HipLOC Hip Fracture Fixation System- Hiploc System 130® Plate 38 mm Barrel 4 Hole Plate Item Number... 2 09/27/2018 Biomet UK Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 135® Plate 38 mm Barrel 4 Hole Plate Item Number:... 2 09/27/2018 Biomet UK Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 140® Plate 38 mm Barrel 4 Hole Plate Item Number:... 2 09/27/2018 Biomet UK Ltd.
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product ... 2 04/22/2024 Biomet, Inc.
Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 14122... 2 04/28/2011 Biomet, Inc.
Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141... 2 04/28/2011 Biomet, Inc.
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Produ... 2 11/24/2007 Biomet, Inc.
CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, ... 2 03/17/2010 Boston Scientific Corp
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730 2 11/25/2019 Boston Scientific Corporation
Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610 2 11/25/2019 Boston Scientific Corporation
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680 2 11/25/2019 Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690 2 11/25/2019 Boston Scientific Corporation
Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Irel... 2 04/11/2012 Boston Scientific Corporation
Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent,... 2 07/15/2011 Boston Scientific Corporation
Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stai... 1 07/27/2004 Boston Scientific Corporation
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup... 3 08/01/2016 Branan Medical Corporation
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insula... 2 05/02/2017 Breg Inc
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insula... 2 05/02/2017 Breg Inc
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an in... 2 05/02/2017 Breg Inc
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an in... 2 05/02/2017 Breg Inc
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulat... 2 05/02/2017 Breg Inc
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insu... 2 05/02/2017 Breg Inc
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulati... 2 05/02/2017 Breg Inc
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings use... 2 05/02/2017 Breg Inc
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide i... 2 09/06/2012 Breg Inc, An Orthofix Company
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment devic... 2 07/06/2015 BTE Technologies, Inc.
Lumbar Tray Catalog 1091 2 05/28/2022 Busse Hospital Disposables, Inc.
Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed ... 2 11/19/2011 C P Medical Inc.
Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed ... 2 11/19/2011 C P Medical Inc.
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF ... 2 09/17/2009 C R Bard Inc
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF ... 2 09/17/2009 C R Bard Inc
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF ... 2 09/17/2009 C R Bard Inc
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF ... 2 09/17/2009 C R Bard Inc
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, ... 2 09/17/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, Sterile E... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile ... 2 04/08/2009 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm, 10cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm, 20cc, Sterile ... 2 12/12/2008 C R Bard Inc
7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard... 2 11/07/2008 C. R.Bard, Inc./BardElectrophysiology Division
Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM000... 2 02/28/2003 C. R.Bard, Inc./Electrophysiology Division

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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