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Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Oct 19, 2017 BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy ... Range for the same energy could be different depending if the layer is the first layer of the ir... Class II Ion Beam Applications S.A.
Oct 19, 2017 BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 18, 2017 Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 m... Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragm... Class II Teleflex Medical
Oct 18, 2017 NucliSENS Lysis Buffer Extended lot for RES 76675 Elute may become colored due to the residual presence of heme group origination from hemoglobin p... Class II BioMerieux SA
Oct 18, 2017 Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... Class II Bioseal Corporation
Oct 17, 2017 Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL... Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheteriz... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheter... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter ma... Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheteri... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sh... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Proteus 235, graphite block 8 IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader Class II Ion Beam Applications S.A.
Oct 17, 2017 Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 ma... Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. Class II Southmedic, Inc.
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 a... The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (c... Class II Siemens Healthcare Diagnostics
Oct 17, 2017 ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume In... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors... During a recent investigation, 3M confirmed that a programming translation error could occur in a... Class II 3M Company - Health Care Business
Oct 17, 2017 Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code:... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 16, 2017 STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe... A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in th... Class III Keystone Dental Inc
Oct 16, 2017 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... Class II Stryker Instruments Div. of Stryker Corporation
Oct 16, 2017 Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... Class II Fukuda Denshi Co., Ltd.
Oct 16, 2017 Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remi... Beckman Coulter has identified that due to a software nonconformity in connection with a changed ... Class II Normand Informatique
Oct 16, 2017 Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, whi... Hydrogel peeling from the pads. Class II C.R. Bard, Inc.
Oct 16, 2017 DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep ... Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled ... Class II DeRoyal Industries Inc
Oct 14, 2017 MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved... Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen... Class II Medtronic Minimally Invasive Therapies Group
Oct 13, 2017 Newton Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Rosen Curved Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 TFE Coated Curved Newton LLT Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Bentson Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Disposable Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Plus Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Central Venous Catheter Tray Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Extra Stiff Whisker Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Left Atrial Catheter Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. Class II Ecolab, Inc.
Oct 13, 2017 Double Flexible Tipped Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Femoral Artery Pressure Monitoring Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Cerebral Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.