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U.S. Department of Health and Human Services

Medical Device Recalls
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Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between... 2 09/12/2023 Keystone Industries
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with ... 2 07/27/2023 Davol, Inc.
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a ... 2 07/27/2023 Davol, Inc.
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a ... 2 07/27/2023 Davol, Inc.
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish 2 06/08/2023 Young Dental Manufacturing I, LLC
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog num... 2 04/04/2023 Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog ... 2 04/04/2023 Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog num... 2 04/04/2023 Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog num... 2 04/04/2023 Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog num... 2 04/04/2023 Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog num... 2 04/04/2023 Stryker Corporation
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION ... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
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
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II 2 07/06/2022 Chromsystems Instruments & Chemicals GmbH
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I 2 07/06/2022 Chromsystems Instruments & Chemicals GmbH
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 2 10/19/2021 ADRIA SRL
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715 2 10/19/2021 ADRIA SRL
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 2 10/19/2021 ADRIA SRL
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile M... 2 07/12/2021 Tornier, Inc
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is mad... 2 05/26/2021 CooperSurgical, Inc.
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed... 2 02/22/2021 Covidien Llc
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Us... 2 02/02/2021 Mar-Med Co
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm 2 12/03/2020 Ethicon, Inc.
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H... 2 09/30/2020 Beckman Coulter Inc.
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid® ACD is indicated fo... 2 08/13/2020 Intrinsic Therapeutics, Inc.
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has applica... 2 06/03/2020 Covidien Llc
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product ... 2 06/03/2020 Covidien Llc
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product ... 2 06/03/2020 Covidien Llc
Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has applica... 2 06/03/2020 Covidien Llc
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING... 2 05/06/2020 Delfi Medical Innovations, Inc.
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 008... 2 04/27/2020 Stryker Sustainability Solutions
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin S... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usa... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder... 2 01/28/2020 Zimmer Surgical Inc
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.... 2 12/30/2019 Medicrea International
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For ... 2 12/09/2019 Young Dental Manufacturing Co, LLC
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Qu... 2 12/02/2019 Stryker Instruments Div. of Stryker Corporation
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quic... 2 12/02/2019 Stryker Instruments Div. of Stryker Corporation
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K100... 2 05/21/2019 Dornier Medtech America, Inc.
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT CO... 2 04/23/2019 COVIDIEN LLC
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentr... 2 03/21/2019 ACell, Inc
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentr... 2 03/21/2019 ACell, Inc
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast ... 2 01/03/2019 Ultradent Products, Inc.
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15... 2 11/14/2018 Covidien LLC
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump ... 2 11/04/2018 CareFusion 303, Inc.
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each ... 2 11/02/2018 3M Company - Health Care Business
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic t... 3 10/25/2018 Ameditech Inc
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 ... 2 07/13/2018 Medtronic Neuromodulation
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175... 2 07/13/2018 Medtronic Neuromodulation
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporou... 2 04/26/2018 Sofradim Production
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSIT... 2 04/13/2018 Tornier, Inc
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficien... 2 02/23/2018 Atrium Medical Corporation
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified profes... 2 02/14/2018 Zimmer Surgical Inc
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 ... 2 02/14/2018 Zimmer Surgical Inc
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb mass... 2 12/06/2017 Won Industry Co.
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use st... 2 11/08/2017 Sorin Group USA, Inc.
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal... 1 04/07/2017 Medtronic Neurosurgery
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a qua... 2 03/21/2017 BioMerieux SA
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quant... 2 03/21/2017 BioMerieux SA
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (hig... 2 03/21/2017 BioMerieux SA
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a... 2 03/21/2017 BioMerieux SA
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitati... 2 03/21/2017 BioMerieux SA
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a... 2 03/21/2017 BioMerieux SA
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a... 2 03/21/2017 BioMerieux SA
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is ... 2 03/21/2017 BioMerieux SA
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quant... 2 03/21/2017 BioMerieux SA
ETEST® Ceftriaxone TXL32 SPB, Product Name: ETEST® Ceftriaxone TX 0.002-32(low). ETEST is a quantit... 2 03/21/2017 BioMerieux SA
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a qu... 2 03/21/2017 BioMerieux SA
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a qu... 2 03/21/2017 BioMerieux SA
AngioJet® Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Con... 2 03/03/2017 Boston Scientific Corporation
Hernia Pack, part number AMS3859 2 02/28/2017 Windstone Medical Packaging, Inc.
VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive ... 2 01/06/2017 Voco GmbH
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under t... 2 12/14/2016 Oculus Innovative Sciences, Inc.
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatabl... 2 10/28/2016 Stryker Sustainability Solutions
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operat... 2 10/20/2016 Windstone Medical Packaging, Inc.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 801... 2 07/28/2016 Draeger Medical, Inc.
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex ... 2 07/06/2016 Medtronic Navigation
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a... 2 02/29/2016 Cook Inc.
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-1... 2 01/12/2016 Stryker Sustainability Solutions
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx onl... 2 12/10/2015 STERILMED, INC.
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number... 2 11/05/2015 Pyng Medical Corporation
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model ... 2 09/28/2015 STERILMED, INC.
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are i... 2 08/06/2015 Zimmer Surgical Inc
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniqu... 2 08/06/2015 Zimmer Surgical Inc
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific in... 2 12/16/2014 Sam Medical Products
Dharma Cavity Varnish 15mL 2 12/01/2014 Dharma Research, Inc.
Dharma Cavity Varnish with Fluoride 2 12/01/2014 Dharma Research, Inc.
Bard® PerFix Light Plug The Bard® PerFix Light Plug is indicated for reinforcement if soft tiss... 2 11/07/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL A... 1 08/29/2014 Customed, Inc
Bard®Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in t... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the r... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the re... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction ... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of so... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use i... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in th... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
Bard® Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reco... 2 06/02/2014 Davol, Inc., Subs. C. R. Bard, Inc.
 
 
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