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U.S. Department of Health and Human Services

Medical Device Recalls
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Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers... 2 07/22/2021 Exactech, Inc.
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm... 2 01/17/2017 Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number... 2 06/02/2016 Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number... 2 06/02/2016 Exactech, Inc.
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gain... 2 02/03/2014 Exactech, Inc.
Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clea... 2 10/27/2008 Facet Technologies
First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid items, all... 2 11/02/2006 First Aid Only Inc
First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of fi... 2 11/02/2006 First Aid Only Inc
First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other... 2 11/02/2006 First Aid Only Inc
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T... 1 11/29/2016 Greatbatch Medical
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T104... 1 03/06/2014 Greatbatch Medical
HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bott... 2 09/04/2009 Hach Co
NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Numbe... 2 06/09/2007 Hawaii Medical LLC
NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number... 2 06/09/2007 Hawaii Medical LLC
Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is comp... 3 11/04/2006 Home Access Health Corp (HAHC)
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments... 2 02/06/2024 Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instrume... 2 02/06/2024 Howmedica Osteonics Corp.
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixati... 2 01/15/2020 Howmedica Osteonics Corp.
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test ... 2 11/25/2011 Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 te... 2 11/25/2011 Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack: 100 tes... 2 11/25/2011 Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test ... 2 11/25/2011 Immunetech Inc
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. S... 2 07/20/2018 IMPLANTCAST GMBH
Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75m... 2 03/23/2006 International Technidyne Corp
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-1... 2 01/03/2017 Interventional Spine Inc
Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- ... 2 01/11/2012 Interventional Spine Inc
Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A ste... 2 10/13/2011 Interventional Spine Inc
PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A ster... 2 10/13/2011 Interventional Spine Inc
PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the compone... 2 08/18/2011 Interventional Spine Inc
PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the component... 2 07/01/2011 Interventional Spine Inc
PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the component... 2 07/01/2011 Interventional Spine Inc
Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical... 2 05/16/2006 Kimberly-Clark Corporation
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle ... 2 07/13/2013 KooJoo Trading Company
Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delt... 2 11/06/2017 Limacorporate S.p.A
Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Devic... 1 04/09/2015 Lusys Laboratories, Inc.
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Devic... 1 04/09/2015 Lusys Laboratories, Inc.
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pou... 1 04/09/2015 Lusys Laboratories, Inc.
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil po... 1 04/09/2015 Lusys Laboratories, Inc.
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test... 1 04/09/2015 Lusys Laboratories, Inc.
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to h... 2 02/11/2017 Mako Surgical Corporation
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpos... 2 04/28/2016 Mako Surgical Corporation
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by ortho... 2 12/18/2014 Mako Surgical Corporation
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for ... 2 12/18/2014 Mako Surgical Corporation
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for us... 2 12/18/2014 Mako Surgical Corporation
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginat... 3 09/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-... 3 09/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. B... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In ... 2 03/03/2010 Medtronic Navigation, Inc
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CO... 2 10/27/2022 Merit Medical Systems, Inc.
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B,... 2 10/27/2022 Merit Medical Systems, Inc.
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: ... 2 10/11/2018 MicroPort Orthopedics Inc.
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filter... 1 12/17/2013 Nephros Inc
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : ... 1 12/17/2013 Nephros Inc
EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit cont... 2 09/10/2009 Oak Tree International Holdings, LLC, Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul... 2 01/26/2021 OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul... 2 01/26/2021 OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modula... 2 01/26/2021 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Ac... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392... 2 07/25/2018 OMNIlife science Inc.
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Pr... 2 08/21/2015 Omnilife Science Inc.
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty proce... 2 08/17/2014 Ortho Development Corporation
U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver ... 2 01/13/2012 Ortho Development Corporation
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Id... 3 11/02/2015 Ortho-Clinical Diagnostics
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Prod... 2 11/15/2013 Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic ... 2 11/10/2022 Ortho-Clinical Diagnostics, Inc.
U2 Acetabular cup, Ti beads porous coated, ®44mm U2 Acetabular cup, Ti beads porous coated, ®46mm ... 2 05/24/2013 Orthopedic Alliance LLC
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Ar... 2 10/04/2011 Osteomed, Lp
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. Th... 2 01/16/2013 Perkinelmer
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)0643814... 2 05/04/2018 PerkinElmer Life and Analytical Sciences, Wallac, OY
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost El... 2 06/20/2012 Philips Healthcare Inc.
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product ... 2 02/08/2012 Philips Healthcare Inc.
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage:... 2 02/02/2012 Philips Healthcare Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803... 2 03/31/2016 Philips Medical Systems, Inc.
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universa... 2 03/23/2019 Philips North America, LLC
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a mu... 2 03/23/2019 Philips North America, LLC
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 0... 2 08/31/2012 Princeton Biomeditech Corp
Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to val... 2 01/17/2009 Quantimetrix Corporation
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsa... 2 12/23/2015 Rainbow Specialty & Health Products
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the R... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177... 2 08/11/2009 Roche Diagnostics Corp.
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 048377... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the R... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the ... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models... 2 08/11/2009 Roche Diagnostics Corp.
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.;... 2 10/09/2008 Roche Diagnostics Corp.
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminoph... 2 04/25/2018 Roche Diagnostics Corporation
Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Dia... 2 03/16/2011 Roche Diagnostics Operations, Inc.
Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics ... 2 03/16/2011 Roche Diagnostics Operations, Inc.
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagno... 2 09/08/2010 Roche Diagnostics Operations, Inc.

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